BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PER-Q-CATH PLUS 3 FR SINGLE-LUMEN PICC PERIPHERALLY INSERTED

    MDR report key: 1929045 · Received November 16, 2010

    Report

    Report Number
    3006260740-2010-00337
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    August 2, 2010
    Report Date
    November 3, 2010
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K954104
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHARACTERISTICS OF THE DAMAGE FOUND ON THE TUBING THAT WAS RETURNED FOR EVAL ARE CONSISTENT WITH A BREAK IN THE CATHETER TUBING AS APPOSED TO SHARP INSTRUMENTATION. THE COMPLAINT OF CATHETER BREAKAGE IS CONFIRMED, USER-RELATED. THE CATHETER BROKE AT THE DISTAL END OF THE TAPER HUB. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS, FUNCTIONAL AND TACTUAL TESTING SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MFG PROCESS. NO OTHER COMPLICATIONS WITH THIS DEVICE ARE KNOWN. THIS IMPLIES THE DEVICE FUNCTIONED AS DESIGNED UNTIL HE COMPLAINT INCIDENT OCCURRED. THE PRODUCT INSTRUCTIONS FOR USE PROVIDE WRITTEN DIRECTIONS FOR SECURING THE CATHETER AS WELL AS A WARNING THAT EXCESSIVE TENSION CAN CAUSE THE CATHETER TO RUPTURE. A CHR REVIEW SHOWED FOUR OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT (200736, 284311, 289976, 289980, 289981).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT LEAKED FLUID DURING THE INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PER-Q-CATH PLUS 3 FR SINGLE-LUMEN PICC PERIPHERALLY INSERTED LJS C. R. BARD, INC. (BASD) RESF0800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention