MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTOR

Catalog Number 305625

Device Problem Break (1069)

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

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: 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.(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 the locking tab on the bd¿ sharps collector broke.

Manufacturer Narrative

Investigation: no sample could be returned.To return there was a risk of injury present with the damaged and contaminated collector.Only pictures of the issue could be provided for investigation.In the pictures provided a broken part could be identified.There was not enough information for a complete analysis for the part to understand the problem.Unfortunately, the root cause for this issue of locking tab broken was inconclusive.Should additional information become available a more complete investigation may be possible.A possible cause may be overstress to the part.Please read the instructions that are provided inside the package.Also, please read the instructions that are on the label attached to the lid, and please respect the fulfilling limit that is identified on the sharps collector label.Bd will continue to monitor for any trends.

Event Description

It was reported that the locking tab on the bd¿ sharps collector broke.

• Brand Name: BD¿ SHARPS COLLECTOR
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8185918
• MDR Text Key: 131196166
• Report Number: 2243072-2018-01813
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305625
• Device Lot Number: 8184001
• Date Manufacturer Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other