BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 886284 · Received July 27, 2007

    Report

    Report Number
    1710034-2007-00068
    Event Type
    Other
    Date Received
    July 27, 2007
    Date of Event
    July 12, 2007
    Report Date
    July 13, 2007
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE ACTUAL SAMPLE HAD BEEN DISCARDED; HOWEVER, UNUSED UNITS FROM REPORTED LOT NUMBER 7012142 ARE AVAILABLE FOR ANALYSIS. A PREPAID MAILING LABEL HAS BEEN SENT TO THE CUSTOMER FOR RETURN OF REPRESENTATIVE UNITS FROM REPORTED LOT NUMBER 7012142. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PICC WAS INSERTED IN 2007. DURING INSERTION, THE CATHETER BROKE, LEAVING 5CM INSIDE THE PATIENT. A SURGEON WAS CALLED TO REMOVE THE BROKEN PIECE OF CATHETER. THE CATHETER FRAGMENT WAS REMOVED SUCCESSFULLY VIA CUTDOWN AT BEDSIDE WITH SUTURES. THE INFANT HAD JUST HAD SURGERY WHEN THIS EVENT OCCURRED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER PERCUTANEOUS CATHETER LJS BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 7012142

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other