Events

Rappel de Device Recall Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Smiths Medical ASD, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    60449
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0662-2012
  • Date de mise en oeuvre de l'événement
    2011-11-28
  • Date de publication de l'événement
    2012-01-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105987
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Tube, tracheostomy (w/wo connector) - Product Code BTO
  • Cause
    Difficulty disconnecting accessories from the bivona uncuffed neonatal, pediatric and flextend tracheostomy tubes tr3 connector, which may result in a delay in initiating therapy or patient discomfort. if excessive force is used to detach the accessory, this may result in decannulation of the tube which could result in serious injury or death; especially if no replacement tracheostomy tube is imm.
  • Action
    Smith Medical sent an Urgent Field Safety Notice dated November 28, 2011, via U.S. Mail to all affected consignees. The notice identified the product, description of problem, and actions to be taken. This notice included a Customer Information Bulletin and Urgent Field Safety Notice Confirmation Form. Customers were instructed to 1) identify all affected unused product in inventory and segregate it to a quarantine location; 2) complete and return the attached Confirmation Form by fax to 219-989-7259 or email to bivona.tr3@smiths-medical.com; and 3) distributors were instructed to stop distributing and provide Smith Medical with a list of their customers, including contact details, so that Smith Medical can notify the customers of this notice. For questions contact Smiths Medical Customer Service at 800-258-5361, Option 1.

Device

Device Recall Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube
  • Modèle / numéro de série
    Lot numbers: 1704692, 1701038, 1716565, 1725251, 1745569, 1875173, 1883506, 1913103, 1646161, 1667866, 1672035, 1704693, 1725252, 1737209, 1745570, 1754758, 1774611, 1770336, 1774612, 1787324, 1821946, 1821947, 1835018, 1838638, 1851366, 1856145, 1883507, 1896165, 1891550, 1900018, 1915872, 1913104, 1646528, 1646162, 1659133, 1663920, 1667864, 1672043, 1675696, 1704695, 1687697, 1692774, 1725253, 1716566, 1704694, 1721296, 1725255, 1725254, 1729109, 1741717, 1741718, 1754759, 1754760, 1774613, 1770337, 1774614, 1778470, 1774615, 1782701, 1782860, 1787325, 1796660, 1802348, 1809023, 1814057, 1829786, 1842388, 1842389, 1856157, 1851368, 1856147, 1856155, 1856146, 1864876, 1875174, 1875175, 1883508, 1883509, 1891552, 1904059, 1904060, 1913106, 1914886, 1913105, 1635304, 1646163, 1663904, 1663921, 1675688, 1672045, 1667868, 1675691, 1692775, 1687698, 1704697, 1713909, 1716567, 1704696, 1725257, 1729115, 1725256, 1737210, 1741719, 1745571, 1745574, 1754761, 1754762, 1770338, 1774616, 1774617, 1778387, 1782816, 1774618, 1782703, 1782702, 1802349, 1796661, 1782817, 1804342, 1814059, 1814058, 1825880, 1829788, 1829787, 1835019, 1838639, 1842391, 1851369, 1851370, 1860809, 1870280, 1868246, 1856159, 1877992, 1883510, 1883511, 1887738, 1887739, 1900019, 1896167, 1908878, 1896166, 1913108, 1914887, 1908877, 1914888, 1636138, 1646164, 1646165, 1663915, 1663918, 1667867, 1675697, 1672044, 1692777, 1697002, 1692776, 1704699, 1704698, 1716568, 1737211, 1725259, 1725258, 1721295, 1757800, 1757799, 1741720, 1745572, 1770339, 1770340, 1774619, 1774620, 1782704, 1782856, 1778462, 1793460, 1802351, 1802350, 1814060, 1817449, 1825881, 1835020, 1842392, 1851376, 1856161, 1864877, 1883512, 1875177, 1875176, 1883513, 1890728, 1896168, 1904061, 1908879, 1914889, 1646449, 1663905, 1646166, 1667874, 1675699, 1701040, 1704700, 1716569, 1725260, 1721294, 1733050, 1737212, 1745573, 1757801, 1774621, 1754763, 1782705, 1774622, 1782706, 1782822, 1804344, 1782823, 1821948, 1821949, 1838640, 1842393, 1851374, 1851375, 1864878, 1883514, 1883515, 1904063, 1904062, 1915873, 1914890, 1646167, 1631555, 1651838, 1667862, 1672042, 1675698, 1687699, 1701041, 1716570, 1704701, 1729110, 1725262, 1725261, 1745575, 1754767, 1770341, 1774623, 1778480, 1782707, 1796662, 1802352, 1814061, 1817450, 1821950, 1838641, 1851373, 1877993, 1900020, 1860810, and 1908881; Reorder number: 60PFS25, 60PFS30, 60PFS35, 60PFS40, 60PFS45, 60PFS50, and 60PFS55
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide: AZ, CA, CO, CT,DE, FL, GA, HI, IL, IN, KS, KY, LA, SC, TX, OR, NJ, MO, UT, MI, NY, NM, MA, MN, MS, NC, ND, NE, NH, NV, OH, OK, OR, RI, SD, TN, VA, VT, WA, WI, WV including Washinton DC, Australia, Austria, Barbados, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gibraltar, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, New Zeland, Norway, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United States, Vatican City State
  • Description du dispositif
    Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange) || Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Adresse du fabricant
    Smiths Medical ASD, Inc., 5700 W 23rd Ave, Gary IN 46406-2617
  • Société-mère du fabricant (2017)
    Smiths Group Plc
  • Source
    USFDA