BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9323855 · Received November 14, 2019

    Report

    Report Number
    3006260740-2019-03553
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Report Date
    November 14, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FPA
    UDI-DI
    00801741047466
    PMA / PMN Number
    K153440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF ASDQS0241 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MS&S "PATIENT STATES THAT SHE HAS POWERPORT CLEARVUE ISP INSERTED ON (B)(6) 2019. SHE STATES THE FIRST MONTH ACCESS WAS STUCK X 10 TO ACCESS THE POWERPORT. SHE STATES THAT A CHEST X-RAY WAS DONE TO RULE OUT A FLIPPED PORT. PATIENT STATE THE X-RAY DID NOT SHOW A FLIPPED POWERPORT. SHE STATES THE POWERPORT IS NOT PERPENDICULAR AND CANNOT FEEL ALL 3 BUMPS ON THE POWERPORT. PATIENT STATES THAT AFTER 2 MONTHS AFTER PLACEMENT THE POWERPORT WAS ACCESSED WITH MINILOC SAFETY INFUSION SET S02020-10 AND LOT ASBSS0120 WAS USED TO ACCESS THE POWERPORT AND ON SEVERAL OCCASIONS "POPPED OUT OF THE PORT". SHE STATES THEY SWITCH NEEDLES AND SHE IS NOW USING POWERLOC MAX SAFETY INFUSION SET 0142075 WITH LOT ASDQS0241. AND THAT NEEDLE IS "POPPING OUT OF THE PORT." SHE STATES THE DRESSING IS INTACT WITH NEEDLE POPPING OUT. SHE STATES SHE HAS MANY ALLERGIES AND CAN ONLY USE THE IV3000 DRESSING. SHE STATES SHE STATES ACCESSED AT HOME. DENIES EXTREME MOVEMENT OF CHEST OR ARMS. MS&S SUGGESTED TO TRY A LONGER NEEDLE DUE TO THE POWERPORT NOT BEING PERPENDICULAR IN THE CHEST AND THE POWERPORT BEING SLANTED." THIS REPORT ADDRESSES THE POWERLOC MAX SAFETY INFUSION SET USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114669 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN CATHETER,INTRAVASCULAR,THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS FPA BARD ACCESS SYSTEMS N/A ASDQS0241 00801741047466

    Patients

    Seq Age Sex Outcome Treatment
    1