BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY

    MDR report key: 3800554 · Received February 11, 2014

    Report

    Report Number
    3006260740-2014-00043
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 17, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A LEAK (PARTIAL BREAK) IN THE CATHETER IS CONFIRMED, EXACT MECHANISM OF DAMAGE IS UNDETERMINED. GROSS AND MICROSCOPIC EXAMINATIONS OF THE COMPLAINT SAMPLE REVEALED A PARTIAL TEAR IN THE CATHETER TUBING. THE LOCATION OF THE PARTIAL BREAK IS LOCATED BETWEEN THE 36 AND 37 CM DEPTH MARKERS. THE PARTIAL BREAK SITE IS NEARLY PERPENDICULAR TO THE AXIS OF THE TUBING. THE BREAK SITE EXHIBITS SLIGHTLY 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. GROSS VISUAL, MICROSCOPIC AND FUNCTIONAL TESTING SHOWS NO EVIDENCE OF A DEFECT OR 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 REVJ1518 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS INSERTED THE PICC ON (B)(6). ON THE OTHER DAY, WHEN THE NURSE DID REGULAR MAINTENANCE, SHE FOUND THERE WAS A LEAKAGE AT THE SITE OF 37CM. THE LEAK WAS SUBCUTANEOUS AND ANOTHER PICC WAS PLACED FOR FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90032 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY LJS C.R. BARD, INC. (BASD) REVJ1518

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention