BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ARTERIAL CANNULA WITH FLOSWITCH

    MDR report key: 4620577 · Received March 17, 2015

    Report

    Report Number
    2243072-2015-00040
    Event Type
    Injury
    Date Received
    March 17, 2015
    Date of Event
    February 16, 2015
    Report Date
    March 16, 2015
    Manufacturer
    BD
    Product Code
    DWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: 2 SAMPLES, 1 USED AND 1 UNUSED IS A CLOSED PACKAGE, WERE RETURNED FOR EVAL. A VISUAL/MICROSCOPIC EVAL REVEALED A CLEAN CUT AT THE EDGES OF THE BROKEN CATHETER. A VISUAL ANALYSIS OF THE UNUSED SAMPLE REVEALED NO ABNORMALITY. A PULL FORCE TEST WAS CONDUCTED ON THE UNUSED SAMPLE AND IT MET MFG SPECS. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES FOR THE REPORTED LOT NUMBER 4231184. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE IDENTIFIED. HOWEVER, OUT QUALITY ENGINEER NOTES THAT IT IS LIKELY A SHARP OBJECT CUT THE CATHETER OUTSIDE OF THE MFG FACILITY AS THERE IS NO PROCESS IN THE MFG OF THE PRODUCT THAT CAN PRODUCE THIS TYPE OF DEFECT.

    Description of Event or Problem · 1

    THE PT HAD A BD ARTERIAL CANNULA WITH FLOSWITCH BREAK OFF IN THE WRIST. THE CATHETER WAS PLACED 3 HOURS BEFORE A SURGICAL PROCEDURE. IT WAS NOTICED THE NEXT DAY UPON REMOVAL THAT THE CATHETER WAS BROKEN. THIS REQUIRED LOCAL ANESTHESIA AND SURGICAL REMOVAL OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180840 BD ARTERIAL CANNULA WITH FLOSWITCH ARTERIAL CANNULA DWF BD 4231184

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK