BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER PICC SOLO CATHETER WITH SHERLOCK 3CG

    MDR report key: 3242791 · Received July 18, 2013

    Report

    Report Number
    MW5030975
    Event Type
    Injury
    Date Received
    July 18, 2013
    Manufacturer
    BARD ACCESS SYSTEM
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PICC'S (PERIPHERALLY INSERTED CENTRAL CATHETERS) ARE VERY COMMON MEDICAL DEVICES INSERTED INTO AN INDIVIDUALS VASCULATURE TO ADMINISTER CAUSTIC INTRAVENOUS DRUGS. THE TIP OF THE CATHETER LIES AT THE ENTRANCE TO ONES HEART. OUR HOSPITAL'S PICC MFR HAS BEEN INFORMED OF A SERIOUS SAFETY ISSUE, 4 YRS AGO, AND HAS REFUSED TO MAKE A CHANGE. PICC LINES OFTEN INADVERTENTLY MOVE FROM THEIR ORIGINAL SITE CREATING A MULTITUDE OF PROBLEMS LEADING TO BLOOD CLOTS, INFECTION, AND PROLONGED HOSPITALIZATION. A SIMPLE LABEL ADDED TO PICC KITS AND APPLIED TO THE CATHETER AT TIME OF INSERTION WOULD PROVIDE FOR SAFE F/U OF THESE CATHETERS THAT ARE OFTEN IN PLACE FOR WEEKS OR MONTHS. BARD HAS BEEN CONTACTED DOZENS OF TIMES REGARDING THIS ISSUE. THEY ARE COMPLETELY AWARE OF THE AMOUNT OF PICC COMPLICATIONS DUE TO UNDETECTED MOVEMENT OF THEIR CATHETERS. THEY WERE READY TO ADD A LABEL TO THEIR KITS UNTIL THEY DISCOVERED THAT A LABELS' PATENTABILITY IS POOR. APPARENTLY, PROFITABILITY WON-OUT OVER PT SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335419 POWER PICC SOLO CATHETER WITH SHERLOCK 3CG PICC LINE 4FR LJS BARD ACCESS SYSTEM REWG1339
    335527 POWER PICC SOLO CATHETER WITH SHERLOCK 3CG PICC LINE 5FR LJS BARD ACCESS SYSTEM REXA0093
    335528 POWER PICC SOLO CATHETER WITH SHERLOCK 3CG PICC LINE 6FR LJS BARD ACCESS SYSTEM REXB0176

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R