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

Catalog Number 20-1037

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 11/21/2013

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported by the ous affiliate, during cranial surgery, when a raney scalp clip 10 pack was opened there were 11 in the pack.An alternate pack was used; no delays or adverse events recorded.

Manufacturer Narrative

The device has been returned.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Two inner packaging pouches and eleven loose clips were returned for evaluation.While we are unable to definitively confirm that the eleven clips came from a single package, we are confirming the complaint based on the information reported.A review of manufacturing records found no issues related to piece counts.There are several piece count checks in place for this product throughout the processes-the auto bagger deflects rejects according to piece counts and a second scale is to be used to verify 10 counts.Trends will be monitored for this or 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
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6361518
• MDR Text Key: 68426591
• Report Number: 1226348-2017-10126
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• 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: EJ601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1