MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SHARPS CONTAINER

Catalog Number UNKNOWN

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that unspecified bd" sharps container lid was broken.This occurred on 8 occasions.The following information was provided by the initial reporter: material no.: unknown batch no.: unknown.It was reported that 8 lids were broken upon arrival.

Event Description

It was reported that unspecified bd¿ sharps container lid was broken.This occurred on 8 occasions.The following information was provided by the initial reporter: material no.: unknown batch no.: unknown.It was reported that 8 lids were broken upon arrival.

Manufacturer Narrative

H.6.Investigation: without a photo or sample being provided by customer, the complaint of broken lids could not be verified and the root cause remains unknown.There was also no material or lot provided for this incident and without these, the supplier could not conduct an investigation either/ device history record review cannot be performed.

• Brand Name: UNSPECIFIED BD SHARPS CONTAINER
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11606271
• MDR Text Key: 243571796
• Report Number: 2243072-2021-00921
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1