BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RANEYSCLP CLP DSPOSE -200

    MDR report key: 22010874 · Received May 13, 2025

    Report

    Report Number
    3014334038-2025-00062
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 14, 2025
    Report Date
    October 24, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    HBO
    UDI-DI
    10381780511625
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    UPDATED FIELDS - D4, D8, D9, G6, H1, H2, H3, H4, H6, H11. THE SCALP CLIP (ID 201037) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - WAS REVIEWED FOR THE REPORTED PRODUCT¿S LOT NUMBER. AND IT 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 - A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE, AND IT CONFIRMED PRESENCE OF A HAIR ON SEALED PACKAGE. ROOT CAUSE - PER THE COMPLAINT BACKGROUND, HAIR WAS FOUND. THE COMPLAINT WAS CONFIRMED DURING INVESTIGATION AND FAILURE ANALYSIS EVALUATION. DEBRIS PRESENT IN PACKAGING MATERIAL, A POTENTIAL ROOT CAUSE IS OPERATOR ERROR, WORKSTATION NOT CLEAN.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAIR WAS FOUND INSIDE THE STERILIZATION PACK DURING INSPECTION OF A SCALP CLIP (ID 201037). THE PRODUCT WAS STORED IN A WAREHOUSE (DISTRIBUTION CENTER). NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369054 RANEYSCLP CLP DSPOSE -200 SCALP CLIPS HBO INTEGRA LIFESCIENCES MANSFIELD 7466351 10381780511625

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown