BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO HF CATH W/SHER 3CG (TPS) STYLET 5F MAX

    MDR report key: 3871764 · Received April 17, 2014

    Report

    Report Number
    3006260740-2014-00190
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A LEAK IN THE CATHETER WAS CONFIRMED, AND THE CAUSE APPEARS TO BE USER RELATED. THE PRODUCT RETURNED FOR EVAL WAS A 5FR TRIPLE-LUMEN POWERPICC SOLO CATHETER. DISCOLORATION WAS SEEN IN THE TUBING, THROUGHOUT THE EXTENSION TUBING AND CATHETER SHAFT. THE CATHETER APPEARED TO BE TRIMMED AT THE 25CM DEPTH MARKING. A 0.2" LENGTH LONGITUDINAL SPLIT WAS OBSERVED BETWEEN THE 1CM AND 2 CM DEPTH MARKING. THE SAMPLE WAS PATENT TO INFUSION USING WATER FROM A 12CC SYRINGE WITH WATER LEAKING THROUGH THE SPLIT SITE WHEN THE GREY-LUERED LUMEN WAS FLUSHED. MICROSCOPIC EXAMINATION OF THE SPLIT SITE REVEALED A DULL AND GRANULAR FRACTURE SURFACE. THE OUTER SURFACE OF THE SPLIT SITE HAD A RIPPLE-LIKE SHAPE TO THE MATERIAL. THE CHARACTERISTICS OF THE OBSERVED DAMAGE ARE INDICATIVE OF A BURST IN THE LUMEN DUE TO OVER-PRESSURIZATION. THE IFU FOR THIS DEVICE PROVIDES ADEQUATE INSTRUCTION FOR INFUSING THIS DEVICE AS WELL AS FOR AVOIDING BURSTING THE LUMEN BY OVER-PRESSURIZATION. A LOT HISTORY REVIEW (LHR) OF REYB0126 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PICC WAS FOUND PERFORATED AT 2CM MARK IN PT. LEAKING FROM THE INSERTION SITE. THE CATHETER WAS INSERTED TO THE 0CM MARK. PICC WAS REPLACED WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236627 POWERPICC SOLO HF CATH W/SHER 3CG (TPS) STYLET 5F MAX LJS C.R. BARD, INC. (BASD) REYB0126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention