MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLLECTOR 8 QT MULTI-USE NESTABLE

Catalog Number 305343

Device Problem Difficult to Open or Close (2921)

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

Event Date 11/27/2018

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 and the (b)(4) fda registration number has been used for the manufacture report number.(b)(6).Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd sharps collector 8 qt multi-use (b)(4) had temporary lids that did not shut properly.

Manufacturer Narrative

H.6.Investigation summary: no samples or photos were provided.Three attempts to get more information or pictures were made, however in none of the cases additional information were provided.The dhr review process was not performed due to the lot number was not provided.Investigation: according to this investigation this failure mode is already known since previous complaints were received for the same condition throughout 2017.For this reason, a capa record # ca-rj001797 was opened to perform the investigation as well to implement corrective actions.There is not a lot number reported under this complaint, therefore it can¿t be determined if the issue came up before or after corrective action implementation.The corrective action was fully implemented for batches manufactured from 2018 on forward, in accordance to customer complaint records there are no complaints received from batches manufactured after corrective action.Root cause: slot reference dimension was found greater (loose) than drawing specification.Corrective actions.1.Align steel as per drawing requirement.2.Create mold inserts to be replaced if needed, during preventive maintenance.Conclusion: based on this investigation this failure mode was caused due worn out on the mold, a corrective action ca-rj001797 was implemented, and no issues were observed during the effectiveness verification phase.If additional information that indicates that this issue came up after corrective action ca-rj001797, then a new complaint investigation will be open in the flex system to initiate a new investigation path.All the complaint information was captured also for tracking and trending purposes.

Event Description

It was reported that a bd sharps collector 8 qt multi-use nestables had temporary lids that did not shut properly.

• Brand Name: BD SHARPS COLLECTOR 8 QT MULTI-USE NESTABLE
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8156390
• MDR Text Key: 130209428
• Report Number: 2243072-2018-01793
• 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: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• 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: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other