BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR SL POWERPICC SOLO WITH TLS, MAXIMAL BARRIER

    MDR report key: 2110005 · Received April 28, 2011

    Report

    Report Number
    3006260740-2011-00125
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Report Date
    April 5, 2011
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT OF A LEAK IN THE CATHETER IS CONFIRMED. ACCORDING THE NOTES CONTAINED WITH THIS FILE "LINE WAS REMOVED AND TRIMMED DISTALLY." THE DISTAL TIP OF THE CATHETER HAS A SMOOTH, GLOSSY SURFACE INDICATING SEVERANCE BY A SHARP INSTRUMENT SUCH AS SCISSORS OR A SCALPEL. THE CATHETER HAS BEEN SEVERED ON A NEAR 90 DEGREE ANGLE. IT IS NOT KNOWN AS TO THE REASON THE COMPLAINANT CUT THE CATHETER AFTER REMOVAL. IT CAN BE ONLY PRESUMED THE COMPLAINANT SEVERED THE CATHETER TO RENDER THE DEVICE NON-FUNCTIONAL. DURING FUNCTIONAL TESTING A SPRAYING LEAK WAS OBSERVED EMANATING BETWEEN 7 AND 8 CM DEPTH MARKERS. THE LEAK SITE IS <0.4 INCHES IN LENGTH. THE SPLIT EDGES ARE SHARP AND TRANSVERSE IN A STRAIGHT LINE. THE TUBING SURROUNDING THE LEAK SITE IS UNREMARKABLE. APPLYING TENSION CAUSES THE EDGES TO GAPE REVEALING UNIFORM WALLS. IT IS NOT KNOWN THE INDWELL TIME PRIOR TO COMPLAINT INCIDENT. AT THIS TIME THE MECHANISM OF DAMAGE TO THE CATHETER IS UNDETERMINED. GROSS VISUAL, MICROSCOPIC AND FUNCTIONAL TESTING SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MFG PROCESS. A CHR IS NOT POSSIBLE, AS NO MFG LOT NUMBER INFO HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    PICC LINE WAS LEAKING FROM INSERTION SITE. LINE WAS REMOVED AND TRIMMED DISTALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR SL POWERPICC SOLO WITH TLS, MAXIMAL BARRIER LJS C.R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention