BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC PROVENA 3F SL MBPLUS (3CG, BIOPATCH, PROBE COVER)

    MDR report key: 19971840 · Received August 13, 2024

    Report

    Report Number
    3006260740-2024-04423
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 12, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741155031
    PMA / PMN Number
    K180548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DILATORS IN THE 3FR PICC KITS ARE VERY FLIMSY AND DIFFICULT TO FEED THROUGH TISSUE. THE DARK MATERIAL OF THE OUTER DILATOR OFTEN "CRINKLES" UP OR A SMALL PIECE ON THE TOP WILL START TO PEEL BACK, CREATING A KIND OF HANG NAIL AS YOU'RE TRYING TO FEED IT INTO THE VESSEL, AND TYPICALLY UNABLE TO SUCCESSFULLY PLACE THE DILATOR. TODAY, AS I WAS TRYING TO PLACE A 3FR PICC ON A 13-MONTH-OLD. I INITIALLY TRIED SEPARATING THE INNER AND OUTER DILATOR AND FEEDING THE INNER DILATOR THROUGH FIRST, ALLOWING THE VESSEL SOME TIME TO STRETCH AND RELAX. I ALSO MADE A VERY SMALL SUPERFICIAL DERMATOTOMY TO DECREASE RESISTANCE ON THE OUTER DILATOR BUT NONE OF THOSE TRICKS MADE THE DIFFERENCE AND THE PLASTIC ON THE END CURLED BACK ANYWAY. I ENDED UP HAVING TO USE A DILATOR FROM A 4.5FR MICRO KIT." THE CUSTOMER REPORTED THIS AS AN ONGOING OCCURRENCE HOWEVER DID NOT PROVIDE AN EXACT QUANTITY. THIS FILE WILL ADDRESS THE UNKNOWN EVENT(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163777 POWERPICC PROVENA 3F SL MBPLUS (3CG, BIOPATCH, PROBE COVER) CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REHZ1528 00801741155031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other