MAUDE Adverse Event Report: RAYNHAM RANEYSCLP CLP DSPOSE -200; SCALP CLIPS

Catalog Number 201037

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported a brown spot in the sterile pack of the scalp clips.There was no patient involvement.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The scalp clip was returned for evaluation: device history record (dhr): no anomalies occurred during the manufacturing process.Failure analysis - in the failure analysis that was performed, the returned unit did not work as intended as the failure analyst determined there was a brown spot/particulate in the packaging.The complaint could be verified through failure analysis.A 6m root cause analysis was performed exploring the areas of man, method, machine, materials, measures and mother nature.In addition, the "fmea" was reviewed to determine potential causes for contaminants present in the packaging.After review of the 6m areas and the "fmea", the likely root cause is related to man or method.Per the "fmea" a likely cause is an error in the supplier manufacturing process, and depending at which step in the process, it is possible that this could have been attributed to operator error.The complaint was confirmed.

Event Description

N/a.

• Brand Name: RANEYSCLP CLP DSPOSE -200
• Type of Device: SCALP CLIPS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10731452
• MDR Text Key: 213200780
• Report Number: 3014334038-2020-00071
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

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: 201037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1