MAUDE Adverse Event Report: BECTON DICKINSON BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE; NEEDLE CLIPPING DEVICE

Catalog Number 328235

Device Problem Difficult to Open or Close (2921)

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

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.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 bd safe-clip¿ needle clipping & storage devices will not open after clipping.There was no report of exposure, serious injury, or medical intervention.

Event Description

It was reported that bd safe-clip needle clipping & storage devices will not open after clipping.There was no report of exposure, serious injury, or medical intervention.

Manufacturer Narrative

No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.As per qe, a dhr review of the risk management file for this issue shows that the risk for this issue is low.Based on the samples/photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.

• Brand Name: BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE
• Type of Device: NEEDLE CLIPPING DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7992293
• MDR Text Key: 124834930
• Report Number: 2243072-2018-01522
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903282357
• UDI-Public: 382903282357
• Combination Product (y/n): N
• PMA/PMN Number: K943683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328235
• Device Lot Number: 7334560
• Date Manufacturer Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other