BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN

    MDR report key: 9219664 · Received October 22, 2019

    Report

    Report Number
    3006260740-2019-03263
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FPA
    UDI-DI
    00801741047466
    PMA / PMN Number
    K153440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED BY MS&S, "CALLER ASKING IF POWERLOC MAX (PRODUCT # 0142075) HAS A MECHANISM TO PREVENT AIR EMBOLISM AS PATIENT. PRESENTED TODAY FOR TREATMENT WITH NEEDLE IN PORT AND SHE HAD CUT TUBING HERSELF AT HOME ON (B)(4) 2019. CALLER STATES THE TUBING IS NOT BENT OR CLAMPED. CALLER IS UNABLE TO LOCATE REFERENCE/PRODUCT OR LOT NUMBER FOR PORT BUT BELIEVES THAT IT IS A BARD POWERPORT." MS&S RESPONDED, "EXPLAINED TO CALLER THERE IS NO A MECHANISM IN POWERLOC MAX (PRODUCT # 0142075) TO PREVENT AIR EMBOLISM WHEN DAMAGED IN THIS MANNER. INFORMED THAT BEST COURSE IS TO NOTIFY PROVIDER AND CHECK FOR AIR EMBOLISM." ADDITIONAL INFORMATION RECEIVED FROM FACILITY STATED, "THE DEVICE WAS NOT DEFECTIVE, THE PATIENT HERSELF CUT THE TUBING WITH A PAIR OF SCISSORS. THE MANUFACTURER HAD ABSOLUTELY NO FAULT IN THIS SCENARIO. WE DID NOT REPLACE IT BECAUSE WE DIDN¿T PUT IT IN ( THE NEEDLE). AS FAR AS WE KNOW THE PATIENT IS DOING FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014437 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS N/A UNK 00801741047466

    Patients

    Seq Age Sex Outcome Treatment
    1