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

Catalog Number 20-1037

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

As reported by the (b)(4) affiliate, a package of codman patties 10-pack contained 11patties, a codman rainey clip 10-pack contained 21 clips and another codman rainey clip 10-pack contained 11 clips.Once count was done, hospital discarded extra products in packages and continued procedure.There were no reports of delay or patient harm.

Manufacturer Narrative

A follow up report will be filed upon completion of the investigation.Supplier response for the raney clips: we have implemented additional piece count checks for this area throughout time, the 21 count is the one that is tougher to connect with a true root cause.The dhr folders have been reviewed with no indication of miss-counts being recorded.

Manufacturer Narrative

The device was returned for evaluation.Received was an open packet of surgical patties and 11 individual clips.Each pack should contain 10 clips.Based on the package being opened upon receipt, we are unable to conclusively determine at what point the reported issue may have occurred.A dhr review for the reported lots found no manufacturing defects noted during the manufacturing process.Based on the information available, it appears that a device failure has occurred; however, the supplier was not able to determine root cause.The supplier has implemented additional piece count checks.Trends will be monitored for this and similar complaints.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 MA 02767
• MDR Report Key: 7195745
• MDR Text Key: 97880192
• Report Number: 1226348-2018-10074
• Device Sequence Number: 1
• Product Code: HBO
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

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 Catalogue Number: 20-1037
• Device Lot Number: EJ610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 01/16/2018; 02/16/2018
• Supplement Dates FDA Received: 01/31/2018; 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1