BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RANEYSCLP CLP DSPOSE -200

    MDR report key: 21316079 · Received February 5, 2025

    Report

    Report Number
    3014334038-2025-00014
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    December 12, 2024
    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, 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.

    Description of Event or Problem · 0

    A FACILITY REPORTED A FOREIGN OBJECT INSIDE THE PACKAGING OF A SCALP CLIP (ID 201037) DURING INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904851 RANEYSCLP CLP DSPOSE -200 SCALP CLIPS HBO INTEGRA LIFESCIENCES MANSFIELD 7408755 10381780511625

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown