BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC PROVENA 4F DL MBPLUS (3CG)

    MDR report key: 16478856 · Received March 3, 2023

    Report

    Report Number
    3006260740-2023-00644
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    February 9, 2023
    Report Date
    May 31, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741154744
    PMA / PMN Number
    K180548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A BATCH HISTORY REVIEW (BHR) OF REGX2173 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED, LINE WAS REMOVED DUE TO IT BEING POSITIONAL AND MULTIPLE KINKS IN CATHETER. RECOMMEND REPLACEMENT OF PICC SINCE PICC IS EXTREMELY POSITIONAL WITH ARM MOVEMENTS AND TIP IS IN MID SVC WHICH IS NOT IDEAL LOCATION FOR CPN. POSITIONAL ON LINE REMOVAL NOTED MULTIPLE KINKS IN CATHETER. NO XRAY IMAGE OF ARM OBTAINED. ADDITIONAL INFORMATION RECEIVED ON 5/25: CATHETER WAS INSERTED 9CM ABOVE THE ANTECUBITAL FOSSA WITH 4CM LEFT EXTERNAL.

    Description of Event or Problem · 0

    IT WAS REPORTED, LINE WAS REMOVED DUE TO IT BEING POSITIONAL AND MULTIPLE KINKS IN CATHETER. RECOMMEND REPLACEMENT OF PICC SINCE PICC IS EXTREMELY POSITIONAL WITH ARM MOVEMENTS AND TIP IS IN MID SVC WHICH IS NOT IDEAL LOCATION FOR CPN. POSITIONAL ON LINE REMOVAL NOTED MULTIPLE KINKS IN CATHETER. NO XRAY IMAGE OF ARM OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871599 POWERPICC PROVENA 4F DL MBPLUS (3CG) CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REGX2173 00801741154744

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Unknown Other