BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROV 3F SL IR 70CM NI

    MDR report key: 12277614 · Received August 4, 2021

    Report

    Report Number
    3006260740-2021-03140
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 16, 2021
    Report Date
    July 26, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741129971
    PMA / PMN Number
    K180548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REEX1138 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED "PICC PLACED IN OR BY PICC RN USING A C-ARM AND SHERLOCK. TIP NEAR CAJ. CXR DONE IMMEDIATELY AFTERWARDS PER POLICY AND PICC HAD MIGRATED CONTRALATERAL." NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171171 PROV 3F SL IR 70CM NI CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REEX1138 00801741129971

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Other