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

Catalog Number 20-1037

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation a follow up report will be filed.

Event Description

Loose particles detected by stock check (for lot# bh606) in (b)(6).There was no reported patient harm or delay in surgery greater than 30 minutes.

Manufacturer Narrative

Additional information: the device was returned and evaluated by the supplier.The supplier's evaluation confirmed that there was very slight debris within the pouch.The supplier indicated a potential cause to be related to static, which may have caused debris to cling to the bag.A review of manufacturing records was performed and no inconsistencies were noted when the device was released to stock.Operators have been made aware of the issue, and additional steps have been taken to reduce and detect particulates.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: 5394204
• MDR Text Key: 36955032
• Report Number: 1226348-2016-10093
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/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

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: BH606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 01/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2016
• 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