BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2FR SL W/O GW BULK NON

    MDR report key: 10655535 · Received October 9, 2020

    Report

    Report Number
    3006260740-2020-20026
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 15, 2020
    Report Date
    September 25, 2020
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 RECX4405 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (RECX4405) HAVE BEEN REPORTED FROM THE SAME FACILITY IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED, "CATHETER RUPTURE BETWEEN THE BODY AND THE FIXATION PART OF THE CATHETER. AFTER 28 DAYS OF THE CATHETER INSERTION THE NURSE INSTALLED THE NPP, SALINATED THE CATHETER AND WAS WITH NORMAL FLOW. THEN THE NURSING TECHNIQUE WAS MANIPULATED AND SHE OBSERVED THAT THE BODY OF THE CATHETER HAD DISCONNECTED FROM THE FIXATION PART OF THE CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124309 2FR SL W/O GW BULK NON CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A RECX4405

    Patients

    Seq Age Sex Outcome Treatment
    1 Other