BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASOGASTRIC STABILIZATION DEVICES,STATLOCK®,ATTACHED SKIN PREP

    MDR report key: 11918098 · Received June 1, 2021

    Report

    Report Number
    1018233-2021-03164
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    April 15, 2021
    Report Date
    August 19, 2021
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS UNCONFIRMED - PRODUCT MET SPECIFICATIONS. VISUAL EVALUATION NOTED 1 NASOGASTRIC STATLOCK IN OPENED PACKAGING WAS RECEIVED. VISUAL INSPECTION NOTED NO DEFECTS ON THE BUTTERFLY PAD. THE REPORTED COMPLAINT WAS FOR MISSING CLAMP; HOWEVER, NO CLAMP IS PRESENT ON THIS PRODUCT. THE PRODUCT MET SPECIFICATIONS. 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." H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STATLOCK CLAMP WAS NOT ATTACHED TO THE ADHESIVE PAD.

    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 STATLOCK CLAMP WAS NOT ATTACHED TO THE ADHESIVE PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811570 NASOGASTRIC STABILIZATION DEVICES,STATLOCK®,ATTACHED SKIN PREP STATLOCK DEVICE KMK JUEP0200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other