Alerte De Sécurité sur Trade name: BD Plastipak Hypodermic Needleless Syringe. Technical Name: Disposable Syringes. ANVISA registration number: 10033430030. Class of risk: II. Affected Model: BD Plastipak Needleless Hypodermic Syringe 20 mL LL. Serial numbers affected: Lot No: 7088885.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

BD has communicated the customers affected by this field action by sending a letter, which directs them to take the following steps: 1. Immediately carry out the inventory survey to identify the product and lot No. 7088885, segregating all units of this lot. 2. Block all units of Lot No. 7088885 available in stock and immediately stop use; 3. Complete the applicable fields of the form attached to the letter and send it to regulatorio@bd.com, regardless of whether or not you own the units in Lot No. 7088885; 4. Upon confirmation of receipt of the form, BD will contact you to align the collection and replacement of the products. In addition, BD provided free telephone service in the letter by calling 0800 055 5654 or e-mail regulatorio@bd.com to clarify any possible doubts. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 03/11/2017 - Date of notification notice to Anvisa: 11/12/2017 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "