BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARTIN UTERINE

    MDR report key: 3853539 · Received April 3, 2014

    Report

    Report Number
    1416891-2014-00004
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 5, 2014
    Report Date
    April 2, 2014
    Manufacturer
    ANCHOR PRODUCTS COMPANY
    Product Code
    GCJ
    PMA / PMN Number
    K831648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL DID NOT RETURN THE COMPLAINT NEEDLES. ANCHOR PRODUCTS REVIEWED THE MANUFACTURING RECORDS FOR THE LOT NUMBER INVOLVED. THE RECORDS CONFIRMED THAT THE LOT HAD BEEN ASSEMBLED AND TESTED AS DEFINED IN ANCHOR PRODUCTS PROCEDURES AND SPECIFICATIONS. THE TEST RESULTS WERE WITHIN SPECIFICATIONS. ANCHOR PRODUCTS COULD NOT CONFIRM THE FAILURE MODE REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    DOCTOR HAD USED NEEDLES DURING SHOULDER SURGERY. NEEDLE TIPS WERE MISSING AT CONCLUSION AT PROCEDURE. RETRIEVED TIPS ON TWO AND REMOVED REMAINING TIP THROUGH IRRIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202599 MARTIN UTERINE SURGICAL NEEDLE GCJ ANCHOR PRODUCTS COMPANY 1860-6D W01N

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention