MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS - COLLECTEURS D'AIGUILLES; SHARPS CONTAINER

Catalog Number 305624

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: na.Pma/510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.(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 - collecteurs d'aiguilles the cover breaks at the hinge.

Manufacturer Narrative

Investigation summary: 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.Photo samples were provided for this evaluation.About the photos, the lid is positioned correctly but the syringe will not let it close.Conclusion: customer; improper use; container overfilled.

Event Description

It was reported that before use of the bd¿ sharps - collecteurs d'aiguilles the cover breaks at the hinge.

• Brand Name: BD¿ SHARPS - COLLECTEURS D'AIGUILLES
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8148214
• MDR Text Key: 129927147
• Report Number: 2243072-2018-01725
• 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: 12/10/2018
• 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: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other