BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 975368 · Received June 23, 2007

    Report

    Report Number
    1710034-2006-00054
    Event Type
    Other
    Date Received
    June 23, 2007
    Date of Event
    May 18, 2006
    Report Date
    May 26, 2006
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    LJS
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT # REPORTED ON THE MEDWATCH FORM PROVIDED BY THE HOSP WAS AN INCORRECT LOT NUMBER. THE SALES REP PROVIDED THE CORRECT LOT NUMBER AS 5311879. RESULTS: ONE USED UNIT, IN TWO PIECES, WAS REC'D FOR ANALYSIS. THE QUALITY TECH MICROSCOPICALLY EXAMINED THE SAMPLE AND INDICATED THE AREA OF THE BREAK OCCURRED BELOW THE 1 CM TICK MARK. PORTION 1: APPROX 3 CM OF CATHETER TUBING IS ATTACHED TO THE ADAPTER. JAGGED EDGES WERE NOTED AT THE AREA OF THE BREAK. PORTION 2: DAMAGED JAGGED EDGES WERE EVIDENT AT ONE END OF THE CATHETER TUBING WHILE THE OPPOSITE SIDE OF THE TUBING IS TRIMMED SMOOTHLY AND SQUARELY. NO DAMAGE WAS NOTED TO THE STRAIN RELIEF ITSELF AS ALL STRAIN RELIEF MEASUREMENTS MET SPEC REQUIREMENTS. CONCLUSIONS: THE DAMAGED JAGGED EDGES NOTED ARE CONCLUSIVE OF EVIDENCE OF EXCESSIVE STRESS TO THE CATHETER, WHICH RESULTED IN SEPARATION, AND THE MISPLACEMENT OF THE YELLOW STRAIN RELIEF.

    Description of Event or Problem · 1

    CALLED TO CHECK THE 1.9 FRENCH 24 GAUGE PICC BECAUSE THE CATHETER WAS OUT OF THE DRESSING. FOUND PICC WITH STRESS RELIEF PORTION OF CATHETER LOOSE FROM THE HUB AND FLOATING ON THE CATHETER. DRESSING WAS ADDED TO THE CURRENT DRESSING TO COVER AND STABILIZE THE PORTION OF THE PICC THAT WAS EXPOSED. CALL TO FACILITY INDICATED THAT THE STRAIN RELIEF CAME LOOSE FIRST, AND THEN THE CATHETER BROKE INSIDE THE PT UPON REMOVAL. THE CARDIOVASCULAR TEAM WAS ABLE TO REMOVE THE REMAINING PORTION OF THE CATHETER AND NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER PERCUTANEOUS CATHETER LJS BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 5311878

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Other