BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR S/L GROSHONG PICC WITH SAFETY IV CATH, BA

    MDR report key: 2852279 · Received November 12, 2012

    Report

    Report Number
    3006260740-2012-00402
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 21, 2012
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K871998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A PARTIAL BREAK IN THE CATHETER IS CONFIRMED. GROSS AND MICROSCOPIC EXAMINATIONS OF THE COMPLAINT SAMPLE REVEALED A PARTIAL BREAK IN THE CATHETER TUBING. THE LOCATION OF THE PARTIAL BREAK SITE IS LOCATED BETWEEN THE 28 AND 29 CM DEPTH MARKER. THE PARTIAL BREAK SITE IS NEARLY PERPENDICULAR TO THE AXIS OF THE TUBING. THE BREAK SITE EXHIBITS ROUNDED EDGES. THE TUBING SURROUNDING THE PARTIAL BREAK SITE IS SLIGHTLY COMPRESSED. THE CATHETER MAY HAVE BEEN PLACED IN AN AREA WHERE TORQUING AND KINKING IS SUSCEPTIBLE. THESE CHARACTERISTICS OF ROUNDED EDGES AND CROSS SECTIONAL ROUGH WALLS IN THE CATHETER TUBING ARE TYPICAL OF MATERIAL FATIGUE AND FRICTION WEAR; HOWEVER, AT THIS TIME THE EXACT MECHANISM OF DAMAGE IS UNDETERMINED. GROSS VISUAL, MICROSCOPIC AND FUNCTIONAL TESTING SHOWS NO EVIDENCE OF A DEFECT OF DEFORMITY RELATED TO THE MFG PROCESS. THE PRODUCT INSTRUCTIONS FOR USE (IFU) PROVIDE WRITTEN DIRECTIONS FOR SECURING THE CATHETER AS WELL AS A WARNING THAT EXCESSIVE TENSION CAN CAUSE THE CATHETER TO RUPTURE. A LOT HISTORY REVIEW (LHR) OF REVA0418 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    ON (B)(6) 2011 A GROSONG PICC WAS INSERTED, THE CATHETER LENGTH OF 31CM. ON (B)(6) 2012, WHEN THE NURSE FLUSHED THE CATHETER, SHE FOUND LEAKING. WHILE SHE WAS PULLING OUT THE CATHETER, SHE FOUND A LEAK AT 29CM, 2CM INSIDE THE INSERT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR S/L GROSHONG PICC WITH SAFETY IV CATH, BA LJS C. R. BARD INC. (BASD) REVA0418

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention