MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD RANEYSCLP CLP DSPOSE -200; SCALP CLIPS

Catalog Number	201037
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a foreign object inside the packaging of a scalp clip (id 201037) during inspection.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The scalp clip (id 201037) was returned for evaluation.Device history record (dhr) - the reported product lot number was noted that a report was opened, and disposition was to do 100% inspection on material.This issue was not caught during the inspection therefore we have notified supplier.No other anomalies were identified that occurred during the manufacture or packaging of the device.Failure analysis - upon visual inspection of the disposable's packaging, the failure evaluator confirmed the presence of a foreign object inside the pack.The complaint was confirmed.Root cause analysis - a potential root cause is operator error, workstation not clean.

• Brand Name: RANEYSCLP CLP DSPOSE -200
• Common Device Name: SCALP CLIPS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21316079
• Report Number: 3014334038-2025-00014
• Device Sequence Number: 8590469
• Product Code: HBO
• UDI-Device Identifier: 10381780511625
• UDI-Public: 10381780511625
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 201037
• Device Lot Number: 7408755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown