BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS BIOBLOC, 19 CM, ST. 14.5 FRENCH, IR

    MDR report key: 2113545 · Received June 1, 2011

    Report

    Report Number
    3006260740-2011-00161
    Event Type
    Injury
    Date Received
    June 1, 2011
    Report Date
    May 9, 2011
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K053589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF EXTERNAL CATHETER BREAKAGE IS CONFIRMED. THE CHARACTERISTICS OF THE DAMAGE FOUND ON THE COMPLAINT SAMPLE ARE CONSISTENT WITH A BREAK IN THE CATHETER TUBING AS OPPOSED TO SHARP INSTRUMENT DAMAGE. THE BREAK SITE IS LOCATED AT THE DISTAL END OF THE SURECUFF. AT THIS TIME, THE MECHANISM OF DAMAGE IS UNDETERMINED. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS AND FUNCTIONAL TESTING SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MFG PROCESS. A LHR OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PT CAME IN C/O PAIN. WHILE REMOVING THE CATHETER, THE TIP OF THE CATHETER BROKE. THE TIP WAS SNARED FROM THE FEMORAL. ADD'L INFO: PT WAS IN FOR REMOVAL OF PERMCATH AS THERE WAS A FUNCTIONING FISTULA. CUFF WAS 'HANGING' OUT OF THE EXIT SITE WHICH PROMPTED X-RAY. INTERVENTIONAL CARDIOLOGIST REMOVED THE DEVICE WITH A SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS BIOBLOC, 19 CM, ST. 14.5 FRENCH, IR MSD C. R. BARD, INC. (BASD) REUK1290

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention