BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 666239 · Received January 11, 2006

    Report

    Report Number
    MW1037719
    Event Type
    Malfunction
    Date Received
    January 11, 2006
    Report Date
    January 11, 2006
    Manufacturer
    B-D
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT AT HOME. HOME CARE NURSE FLUSHED LINE WITH SLIGHT RESISTANCE. DRESSING & CONNECTOR CHANGED. DURING THIS PROCESS, CATHETER BROKE RIGHT BELOW HUB. CATHETER DISCONTINUED.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3/7/06: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO DISCREPANCIES ASSOCIATED WITH THIS COMPLAINT. WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT AS THE SAMPLE WAS DISPOSED OF. HOWEVER, A CORRECTIVE ACTION HAD BEEN OPENED TO REDUCE THE RISK FOR THIS TYPE OF OUTCOME. THE MOLDING PROCESS HAS BEEN REVIEWED CONCERNING THIS TYPE OF DEFECT AND THESE ARE THE FINDINGS: THERE HAS BEEN NO CHANGE TO THE MOLD OR THE MOLDING PRESS FOR THE 1.9 FR CATHETER. THERE HAVE BEEN NO CHANGES TO THE DESIGN OR THE MFR OF THE MANDRELS BEING USED. THE OPERATORS CURRENTLY PERFORMING THE MOLDING OF THE PARTS WERE TRAINED BY EXPERIENCED OPERATORS. SAMPLINGS OF MOLDED PARTS WERE EXAMINED UNDER HIGH MAGNIFICATION AND NO DAMAGE WAS NOTED ON THE OUTSIDE SURFACE. THE WALL THICKNESS ALONG THE TUBING WAS ALSO CONSISTENT. THIS ISSUE IS CURRENTLY UNDER DISCUSSION CONCERNING ADD'L TESTING NEEDED. A REVIEW OF THE COMPLAINT DATABASE WAS COMPLETED FOR THE PAST TWO YEARS REGARDING ALL CATALOG NUMBERS OF THE 1.9 FR FIRST PICC CATHETERS BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC PICC LINE 2FR LJS B-D * 5047263

    Patients

    Seq Age Sex Outcome Treatment
    1 *