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 08/10/2017

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 ous affiliate, before use on a patient, a pack of raney scalp clips was found to have a hair inside the package.

Manufacturer Narrative

Device was returned for evaluation.Upon completion of the investigation a followup report will be filed.

Manufacturer Narrative

Upon completion of the investigation it was noted that we received a sealed package of rayney scalp clips p/c20-1037, lot# gj610 with a hair inside the package.Complaint confirmed.Supplier evaluation is as follows: containment notes: no product from this time is in inventory-produced & shipped october/november 2016.Root cause of nonconformance: the dhr was reviewed and there is no evidence of what could be a true root cause.Several revisions have been made to the job instructions throughout time-hoods are to be worn and if hoods are not available two hair nets are required.The changing of gloves when leaving the work station and the use of an air-blow prior to placing the bagged clips into the pouch prior to sealing have been added due to "static" being a factor between the plastic polybags & bagged clips.All work stations in general are to be wiped.Corrective action: the complaint was entered into our systems (customer complaints & job packet instructions).Continuous emphasis on keeping all work areas wiped periodically during the shift and posting a photo of the defect was made aware to team members.This work area will also be covered when not in use.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is 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: 6795393
• MDR Text Key: 82773637
• Report Number: 1226348-2017-10621
• 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: 08/15/2017
• 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: GJ610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2017
• 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