BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PPICC SOLO 5FR D/L, 3CG

    MDR report key: 18807505 · Received February 29, 2024

    Report

    Report Number
    3006260740-2024-00819
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    February 2, 2024
    Report Date
    February 14, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K072230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. H3 OTHER TEXT : DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THE SHERLOCK ECG TURNED GREEN WITH DIAMOND AND NO NEGATIVE DEFLECTION HOWEVER, ON XRAY PICC TIP BELOW CARINA NOT CAJ. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898363 PPICC SOLO 5FR D/L, 3CG CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REGV1364

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other