BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATLOCK DIALYSIS BUTTERFLY TRICOT, HYDROCOLLID

    MDR report key: 6175926 · Received December 15, 2016

    Report

    Report Number
    3006260740-2016-00666
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 20, 2016
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KMK
    UDI-DI
    00801741081637
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NURSE

    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 MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUAPF372 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN MAKING STATLOCK CHANGES, IN THE FIRST CHANGE, THE WHITE CLIP DIDN'T OPEN AND REQUIRED FORCE WITH SCISSORS AND FORCEPS TO OPEN IT JEOPARDIZING THE INTEGRITY OF THE PATIENT AND DAMAGING THE CATHETER. IN THE OTHER CHANGES, THE CLIP DIDN'T CLOSE PROPERLY. ON 11/22/2016 - DURING INVESTIGATION, IT WAS DISCOVERED THAT THE STATLOCK DOOR OPENED SPONTANEOUS WHEN TOUCHED BUT WITHOUT ENGAGING THE RELEASE BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828557 STATLOCK DIALYSIS BUTTERFLY TRICOT, HYDROCOLLID INTRAVASCULAR CATHETER SECUREMENT DEVICE KMK BARD ACCESS SYSTEMS JUAPF372 00801741081637

    Patients

    Seq Age Sex Outcome Treatment
    1