MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS CONTAINER

Catalog Number 305624

Device Problem Break (1069)

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

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed in sections and the (b)(4) fda registration number has been used for the manufacture report number.(b)(6).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 before use of the bd¿ sharps container the cover breaks at the hinge.

Event Description

It was reported that before use of the bd¿ sharps container the cover breaks at the hinge.

Manufacturer Narrative

Investigation summary: a sample was returned for evaluation.Pictures were taken of the actual container as the sample was filled with contaminated material.Testing was performed with a representative sample for the lid by the supplier with no issues found.Also, no issue was registered during the manufacturing for this product.The photo samples were provided for this evaluation to the supplier.In the photos, the lid is positioned correctly but the syringe at the top will not let it close.The root cause appears to be an overfilled container.The content has prevented the lid from locking.

• Brand Name: BD¿ SHARPS CONTAINER
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8156797
• MDR Text Key: 130326712
• Report Number: 2243072-2018-01777
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 02/15/2019

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: 305624
• Device Lot Number: 8135001
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other