BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 FR D/L GROSHONG PICC CATHETER

    MDR report key: 3770086 · Received January 28, 2014

    Report

    Report Number
    3006260740-2014-00026
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Report Date
    November 7, 2013
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF SPLIT IN THE CATHETER WAS CONFIRMED AND THE CAUSE APPEARS TO BE USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS A 5 FR D/L GROSHONG PICC CATHETER. GROSS VISUAL EXAMINATION OF THE SAMPLE REVEALED TRACES OF ADHESIVE ALONG THE LENGTH OF THE CATHETER. THE DISTAL SEGMENT OF THE TUBING WAS COMPLETELY REMOVED AT THE 25CM DEPTH MARKING PRIOR TO EVALUATED SAMPLE'S ARRIVAL. MICROSCOPIC EXAMINATION OF THE SAMPLE REVEALED A LONGITUDINAL SPLIT AT THE 43CM DEPTH MARKING OF THE CATHETER. A CLOSER INSPECTION OF THE SLIT REVEALED NO STRIATIONS FROM THE OUTER WALL TO THE INNER WALL FROM WHERE THE SPLIT OCCURRED. THE INNER LUMEN OF THE CATHETER DID NOT CONTAIN ABRASION DAMAGE OR STRIATIONS. AN ATTEMPT WAS MADE TO INFUSE WATER THROUGH THE CATHETER USING A 12CC SYRINGE. THE CATHETER WAS PATENT TO INFUSION WITH A SPRAYING LEAK AT THE AFOREMENTIONED SPLIT SITE. TACTILE EVALUATION OF THE CATHETER SHOWED TENSILE WEAKNESS AT THE SPLIT SITE. THE CATHETER AND STYLET ASSEMBLY WAS MEASURED TO BE 33.5CM LONG, THE SLIT WAS LOCATED 16.7CM AWAY FROM THE RED PROXIMAL LUER. THE OBSERVED DAMAGE IN CHARACTERISTIC OF CATHETER OVER-PRESSURIZATION (BURST) DAMAGE. AN LHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED B THE COMPLAINANT.

    Description of Event or Problem · 1

    SPLIT ON BLUE SILICONE PART OF PICC NEAR WHITE BUTTERFLY. DURING INVESTIGATION A LEAK WAS FOUND TO BE AT THE 43CM MARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61447 5 FR D/L GROSHONG PICC CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM LJS C.R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention