BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4FR SL PQC PICC

    MDR report key: 755334 · Received August 25, 2006

    Report

    Report Number
    1720496-2006-00240
    Event Type
    Injury
    Date Received
    August 25, 2006
    Report Date
    August 1, 2006
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED. THE 4FR S/L PER-Q-CATH TUBING WAS BROKEN AT THE 5 CM DEPTH MARK. THE CROSS SECTION OF THE BREAK WAS GRANULAR. THERE WAS NO EVIDENCE OF ANY MANUFACTURING RELATED DEFECTS. THE EXACT CAUSE OF THE BREAK IS UNKNOWN.

    Description of Event or Problem · 1

    UNABLE TO INFUSE OR ASPIRATE CATHETER. PATIENT WAS SENT TO X-RAY; THE CATHETER HAD FRACTURED AND EMBOLIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4FR SL PQC PICC IMPLANTED LONG TERM INTRAVSCULAR DQO C.R. BARD, INC. (BASD) * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention