BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROPICC

    MDR report key: 20926334 · Received December 13, 2024

    Report

    Report Number
    3015060232-2024-00030
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 13, 2024
    Manufacturer
    ACCESS VASCULAR INC.
    Product Code
    LJS
    UDI-DI
    00850030354303
    PMA / PMN Number
    K193015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS INSERTED ON (B)(6) 2024, FOR IV ANTIBIOTICS. ON (B)(6) 2024, THE PATIENT EXPERIENCED BICEP PAIN AND THE NURSE WAS UNABLE TO ACHIEVE BLOOD RETURN. AN X-RAY OF THE PATIENT'S ARM IDENTIFIED A KINK APPROXIMATELY 10CM PAST THE INSERTION SITE. THE LINE WAS REMOVED AND A FRACTURE WAS OBSERVED AT THE LOCATION OF THE KINK. NO PHOTOS WERE TAKEN AND THE CATHETER WAS DISPOSED OF BY THE SITE. A REVIEW OF THE LOT HISTORY REVEALED NO NONCONFORMANCES ASSOCIATED WITH THE PRODUCTION LOT. IN FURTHER DISCUSSION WITH THE COMPLAINANT, THEY STATED THAT THEY BELIEVED THE KINK WAS CAUSED BY ACTIVATION OF THE BICEP MUSCLE WITH SUBSEQUENT DISPLACEMENT OF THE CATHETER. THEY ALSO NOTED THAT UPON DISCOVERY OF THE KINK, THE LINE WAS FLUSHED "AGGRESSIVELY" BY THE NURSE, WHICH CAUSED THE CATHETER TO FRACTURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A HYDROPICC LINE THAT KINKED AND FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2414753 HYDROPICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ACCESS VASCULAR INC. PICC-142CM 09252410 00850030354303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown