MAUDE Adverse Event Report: BECTON DICKINSON BD¿ MULTI-USE NESTABLE SHARP COLLECTOR, 8 QT HINGE CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 305343

Device Problem Difficult to Open or Close (2921)

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

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed.The (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.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 the temporary lids of a bd¿ multi-use nestable sharp collector, 8 qt hinge cap didn¿t shut.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7261929.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 7225923.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 7272938.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 7230933.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bdj received 6 boxes.(2 boxes of lot 7261929, 2 boxes of lot 7225923, 1 box of lot 7272938 and 1 box of lot 7230933.) bdj checked half lids from each box and found 1 lid of lot7261929(cavity#1510-3/2011-1)opened immediately after it was shut.The rest could keep closed over 10min.According to this investigation this failure mode is already known since previous complaints were received for the same condition throughout 2017 reason why a capa record # (b)(4) was opened to perform the investigation and to implement corrective actions.It was not confirmed if the defective product reported in this complaint arose from a lot manufactured after of the implementation of the corrective actions due to the lot number was unknown.Corrective actions were full implemented for batches manufactured from 2018 onwards.Investigation conclusion: based on this investigation this failure mode was caused due worn out on the mold, the corrective actions were implemented and evaluated as effective.Root cause slot reference dime:nsion was found greater (loose) than drawing specification.Supplier corrective actions align steel as per drawing requirement.Create mold inserts to be replaced if needed, during preventive maintenance.

• Brand Name: BD¿ MULTI-USE NESTABLE SHARP COLLECTOR, 8 QT HINGE CAP
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7484356
• MDR Text Key: 107323273
• Report Number: 2243072-2018-00223
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 50382903053433
• UDI-Public: 50382903053433
• Combination Product (y/n): N
• PMA/PMN Number: K943134
• 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: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305343
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other