BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19971828 · Received August 13, 2024

    Report

    Report Number
    3006260740-2024-04422
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 16, 2024
    Report Date
    October 4, 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 COMPLAINT OF DAMAGED MICROINTRODUCER IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE PHOTOGRAPH OF A MICROINTRODUCER WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE PHOTOGRAPH SHOWED A MICROINTRODUCER WITH BUCKLING AND SOME PLASTIC DEFORMATION ON THE DISTAL END OF THE PTFE SHEATH. EVIDENCE OF USE AS WELL AS BIOLOGICAL RESIDUE WAS OBSERVED ON THE SAMPLE IN THE RETURNED PHOTOGRAPH. ALTHOUGH DAMAGE WAS OBSERVED ON THE DISTAL END OF THE SHEATH, NO DETAILS OR DISTINGUISHING FEATURES OF THE DAMAGE CAN BE DISCERNED FROM THE RETURNED PHOTOGRAPH WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    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 MANUFACTURER HAS RECEIVED THE SAMPLE AND IT WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.

    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." THIS FILE ADDRESSES THE 13 MONTH OLD PATIENT.

    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." THIS FILE ADDRESSES THE 13 MONTH OLD PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163765 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 13 MO Unknown Other