MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD¿ SYRINGES WITH NEEDLES LUER SLIP

Catalog Number 990147

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8054991, medical device expiration date: 2023-02-28, device manufacture date: 2018-02-23.Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that bd¿ syringes with needles luer slip had an issue with leakage between the needle hub and the syringe tip, where the needle is attached.

Manufacturer Narrative

Investigation: customer returned (10) 1ml, 13mm bd plastipak syringes in sealed blister packs from lot # 8054991.Customer states that medicine leaks between the needle hub and the syringe tip, where the needle is attached.All samples were tested and all were able to draw and expel properly without any observed leakage or any other defects.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.

Event Description

It was reported that bd¿ syringes with needles luer slip had an issue with leakage between the needle hub and the syringe tip, where the needle is attached.

• Brand Name: BD¿ SYRINGES WITH NEEDLES LUER SLIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8207013
• MDR Text Key: 131767023
• Report Number: 3003916417-2018-00380
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K010188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990147
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other