BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3952970 · Received May 20, 2014

    Report

    Report Number
    2134070-2014-00102
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    April 23, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K111002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH THE SLEEVE COMPONENT BROKEN APART AT THE SEAM AND SEAL COMPONENT BROKEN APART AT RETURNED WITH THE DEVICE. THE DEVICE COULD NOT BE PRESSURE TESTED IN ITS RETURNED CONDITION. NO LOT NUMBER WAS PROVIDED SO THE DHR COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE CAME APART WHEN INSTRUMENTS WERE PULLED OUT OF IT. THE TOP KEPT COMING OFF AND THE GAS WAS LET OUT. THERE WAS NO PT INJURY. ADDITIONAL INFO WAS REQUESTED, BUT NO ADDITIONAL INFO WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299309 NA NLM STERILMED, INC. APPCTS02

    Patients

    Seq Age Sex Outcome Treatment
    1