BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASOGASTRIC STABILIZATION DEVICES,STATLOCK®,ATTACHED SKIN PREP

    MDR report key: 11793760 · Received May 7, 2021

    Report

    Report Number
    1018233-2021-02673
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    March 29, 2021
    Report Date
    September 9, 2021
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED. VISUAL EVALUATION NOTED 1 OPENED EMPTY STATLOCK NASOGASTRIC PACKAGE WITH PREP PAD. VISUAL EVALUATION NOTED AN IMPRESSION OF THE BUTTERFLY PAD IN THE PACKAGING. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE INVESTIGATION WAS INCONCLUSIVE. ALTHOUGH AN EXACT ROOT CAUSE COULD NOT BE DETERMINED, A POTENTIAL ROOT CAUSE WAS INADEQUATE MATERIAL SELECTION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "CONTRAINDICATIONS: KNOWN TAPE OR ADHESIVE ALLERGIES. WARNINGS AND PRECAUTIONS: AVOID CONTACTING THE STATLOCK DEVICE WITH ALCOHOL OR ACETONE, BOTH CAN WEAKEN BONDING OF COMPONENTS AND THE STATLOCK DEVICE PAD ADHERENCE." CORRECTIONS: H THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER FOUND OUT THAT THERE WAS NO CORE WITH THE STATLOCK AFTER OPENING THE PACKAGE. STATED THAT IT WAS TOO SQUISHY TO USE. PER FOLLOW UP RECEIVED VIA IBC ON 05OCT2021, THE STATLOCK WASN¿T ABLE TO CLOSE PROPERLY.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER FOUND OUT THAT THERE WAS NO CORE WITH THE STATLOCK AFTER OPENING THE PACKAGE. STATED THAT IT WAS TOO SQUISHY TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685111 NASOGASTRIC STABILIZATION DEVICES,STATLOCK®,ATTACHED SKIN PREP STATLOCK DEVICE KMK JUEP0200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other