BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATLOCK DIALYSIS CLAMSHELL RETAINER ON TRICOT HYDROCOLLOID BUTTERFLY PAD

    MDR report key: 6056070 · Received October 25, 2016

    Report

    Report Number
    3006260740-2016-00565
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 4, 2016
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KMK
    UDI-DI
    00801741081644
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD 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 BARD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THAT THE CLOSURE ON THE DIALYSIS STATLOCK IS NOT HOLDING, THUS THE DIALYSIS CATHETERS ARE NOT PROPERLY FIXED. FACILITY IS USING ADDITIONAL ADHESIVE TAPE ON THE LOCK TO FIX THE CATHETER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707107 STATLOCK DIALYSIS CLAMSHELL RETAINER ON TRICOT HYDROCOLLOID BUTTERFLY PAD INTRAVASCULAR CATHETER SECUREMENT DEVICE KMK BARD ACCESS SYSTEMS UNK 00801741081644

    Patients

    Seq Age Sex Outcome Treatment
    1