BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR SL POWERPICC SOLO NURSE FULL WITH MI

    MDR report key: 2151243 · Received June 21, 2011

    Report

    Report Number
    3006260740-2011-00193
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K072230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A PIN HOLE LEAK IN THE CATHETER WAS CONFIRMED BUT THE CAUSE IS UNK. BROWN RESIDUAL MATERIAL WAS SEEN ALONG THE LENGTH OF THE EXTENSION TUBING AND BETWEEN THE 5 CM AND 6CM MARKINGS OF THE CATHETER. THE CATHETER TUBING EXTENDED APPROX 9.9" FROM THE SUTURE WING HUB. A 12 CC SYRINGE WAS FILLED WITH WATER AND ATTACHED TO THE PROXIMAL LUER. THE SYRINGE PLUNGER WAS PUSHED AND WATER INFUSED THROUGH THE CATHETER WITHOUT RESTRICTIONS, AND A SMALL LEAK WAS SEEN NEAR THE 5 CM MARKING ON THE CATHETER. MICROSCOPIC EXAMINATION WAS PERFORMED AT THE SITE OF THE LEAKAGE. A SMALL LONGITUDINAL TEAR WAS SEEN IN THE CATHETER JUST DISTAL TO THE 5 CM MARKING. TACTILE EXAMINATION OF THE CATHETER WAS UNREMARKABLE. THE EXACT MECHANISM WHICH CAUSED THE SPLIT IN THE TUBING IS UNK AT THIS TIME. GROSS VISUAL AND MICROSCOPIC EXAMINATION, AS WELL AS FUNCTIONAL TESTING, REVEALED NO EVIDENCE OF DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. A LOT HISTORY REVIEW (LHR) OF REVA1229 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PIN POINT HOLE NEAR INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR SL POWERPICC SOLO NURSE FULL WITH MI LJS C.R. BARD, INC. (BASD) REVA1229

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention