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 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Possible lot numbers: kg610, ej608, ej612, gj600, or ej606.Upon completion of the investigation a follow up report will be filed.

Event Description

It was reported from distributor, (b)(6), that it was found a foreign material (white pellet) inside of a package of 20-1037 delivered from (b)(6).This was detected during the repacking process at (b)(6) on (b)(6) 2017.The suspected lot number was one of kg610, ej608, ej612, gj600, or ej606.There was no surgical delay and no adverse consequences to the patient.No further information was provided by the customer.

Manufacturer Narrative

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

Manufacturer Narrative

A bag of clips was returned for evaluation.It was confirmed that there was a white pellet in the bag.A review of the potential lots provided was performed and no discrepancies were found.The supplier's evaluation of the returned pouch found what appeared to be a bead of resin (raw material) used in the molding process.During molding the clips fall into a bin, which are then inspected/packaged for bagging at a later time.The clips are then bagged/sealed in counts of 10, to be pouched into the final tyvex pouch.This stray bead of resin (raw material) may have carried thru due to static.Based on the supplier's evaluation, the reported issue was confirmed.A review of complaint records did not find any similar complaints against any of the potential lots provided.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: 6456454
• MDR Text Key: 72943663
• Report Number: 1226348-2017-10230
• 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: 04/04/2017
• 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: SEE ADDITIONAL INFORMATION
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2017
• 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