BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAFETY T-CENTESIS CATHETER DRAINAGE TRAY

    MDR report key: 909799 · Received September 10, 2007

    Report

    Report Number
    1423507-2007-00099
    Event Type
    Other
    Date Received
    September 10, 2007
    Date of Event
    August 15, 2007
    Report Date
    September 10, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT SAMPLE WAS PROVIDED FOR EVALUATION. A REVIEW OF THE COMPLAINT REPORT IDENTIFIED A POTENTIAL ROOT CAUSE FOR THE FAILURE MODE. PER THE REPORT, THE SYRINGE WAS NOT LIGHTLY SECURED TO THE NEEDLE HUB. THE PRODUCT INSTRUCTIONS CAUTION THE USER TO "ENSURE ALL LUER-LOCK CONNECTIONS ARE SECURE BEFORE USING DEVICE." A REVIEW OF ALL APPLICABLE DOCUMENTATION DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE FAILURE MODE. THE INVESTIGATION DID NOT IDENTIFY ANY DEFINITIVE ROOT CAUSES SINCE A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVALUATION. THIS INFORMATION WILL BE ENTERED INTO THE COMPLAINT TRACKING SYSTEM FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    DR. REPORTED THAT AFTER HE HAD ENTERED THE PERITONEAL SPACE, HE WAS PULLING BACK WHEN THE NEEDLE FLEW OFF AND SPLASHED PERITONEAL FLUID ALL OVER HIS FACE. THE NEEDLE SEPARATED FROM THE RED PROTECTOR AT THE HUB. PT HAD HEPATITIS C, SO DR. HAD A BLOOD TEST DONE. NOT SURE OF THE LOT NUMBER ACTUAL PRODUCT USED; LOT REPORTED WAS TAKEN FROM PRODUCT ON THE SHELF. ACTUAL PRODUCT USED NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY T-CENTESIS CATHETER DRAINAGE TRAY CATHETER DRAINAGE TRAY GCB CARDINAL HEALTH PIG1260T L7B305 ON SHELF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention