MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. RANEY SCALP CLIPS; CLIPS, SCALP

Model Number 20-1037

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that the raney scalp clip container had more than expected.There were 11 products were enclosed in a box instead of 10 products with in the box.It was confirmed at the medical device agent.There is no report of patient harm.No further information was provided by hospital.The product will be returned to your site.

Manufacturer Narrative

The previously reported lot number was incorrect.This report has been updated with the corrected information.The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The device was returned for evaluation.It was confirmed that the packet contained an extra clip.A review of manufacturing records was performed and found no discrepancies related to miscount.The supplier was made aware of this issue.Their investigation found that this device was manufactured in 2017.An increased lot inspection specification was added subsequent to this lot's production.Based on the results of the investigation, the reported issue is confirmed and the root cause its likely manufacturing error.A review of complaint records was performed and this product is not exceeding its upper control limit for this failure type.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: RANEY SCALP CLIPS
• Type of Device: CLIPS, SCALP
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham 02767
• MDR Report Key: 7738560
• MDR Text Key: 115777915
• Report Number: 1226348-2018-10538
• Device Sequence Number: 1
• Product Code: HBO
• UDI-Device Identifier: 20886704001154
• UDI-Public: (01)20886704001154(10)MJ957
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20-1037
• Device Catalogue Number: 20-1037
• Device Lot Number: MJ657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 08/23/2018; 10/23/2018
• Supplement Dates FDA Received: 09/13/2018; 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1