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 Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A hair was found in the sterile package.Event occurred prior to surgery, no delays, no adverse consequences; surgeon didn't open package, sent it to purchasing.On (b)(6) 2015 per rep, reported contamination inside sterile barrier.

Manufacturer Narrative

It was initially reported that the device would be returned for evaluation.Multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records was performed by the supplier and no nonconformances were noted.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.At present, we consider this complaint to be closed.Trends will be monitored for this or similar complaints.Device not returned.

• 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: 5245645
• MDR Text Key: 31992612
• Report Number: 1226348-2015-10700
• 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
• 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

• Date FDA Received: 11/24/2015
• 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: BH607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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