BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLOC

    MDR report key: 9664939 · Received February 4, 2020

    Report

    Report Number
    9664939
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    December 18, 2019
    Report Date
    December 23, 2019
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHAT HAPPENED: RN ACCESSED PATIENT PORT AND AFTER THE NEEDLE WAS INSERTED, SHE FLUSHED AND THE WHITE CAP CLOSEST TO THE NEEDLE/PATIENT FLEW OFF AND SALINE SPRAYED OUT ONTO THE PATIENT'S SHIRT. NORMAL FORCE WAS USED WHEN FLUSHING. PRODUCT: (POWER LOC MAX HUBER NEEDLE 19G 1 INCH REF #0131910, LOT #ASDR075). WHY IT HAPPENED: POSSIBLE DEFECTIVE PRODUCT. CAP ON POWER LOC MAX HUBER NEEDLE TUBING PORT CLOSEST TO THE NEEDLE CAME OFF DURING FLUSHING. TUBING DID NOT APPEAR TO BE CRACKED, CAP DID NOT STAY ON AS IT NORMALLY DOES, MAY HAVE BEEN LOOSE OR DEFECTIVE. THIS HAS REPORTEDLY OCCURRED ON ONE OTHER OCCASION IN THE INFUSION CENTER IN RECENT WEEKS. HOW ARE WE PREVENTING THIS: ASKED NURSES TO TRY TO CHECK CAP IS TIGHT PRIOR TO FLUSHING AND CONTINUE TO MONITOR AND SAFETY NET ANY POSSIBLE DEFECT IN PRODUCT. DEFECTIVE PRODUCT INFORMATION FORM WAS FILLED OUT ALONG WITH COPY OF PRODUCT PACKAGING THAT WAS SAVED AND SENT TO SUPPLY CHAIN. HUBER NEEDLE ITSELF WAS NOT KEPT BUT WILL TRY TO KEEP ANY FURTHER DEFECTIVE PRODUCT IN THE FUTURE. OUTCOME: RN WAS ABLE TO PLACE ANOTHER STERILE CAP IN PLACE OF CAP THAT CAME OFF AND FINISHED FLUSHING PORT. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126593 POWERLOC SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS, INC. 0131910 ASDRF075

    Patients

    Seq Age Sex Outcome Treatment
    1 14235 DA