BEUDAMED
    FDA Adverse Event Injury Summary report: N

    21GX.75" BD VACUTAINER® WINGED SAFETY PBBCS, 12" TUBING, LUER ADAPTER

    MDR report key: 6091484 · Received November 9, 2016

    Report

    Report Number
    1710034-2016-00051
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 28, 2016
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JKA
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - THE MANUFACTURING SITE RECEIVED FOUR 21G PBBCS WITHIN SEALED PACKAGES FROM THE REPORTED LOT 6236616. ALL COMPONENTS WERE PRESENT AND INTACT. THERE WAS NO DAMAGE TO THE PACKAGING. THERE WERE NO ANOMALIES OR DAMAGE TO THE UNITS/COMPONENTS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER. CONCLUSION - CONFIRMATION OF THE REPORTED FAILURE WAS INCONCLUSIVE WITH THE UNITS RECEIVED AND TESTED FOR THIS INCIDENT. THERE WAS NO PHYSICAL OR MECHANICAL EVIDENCE CONFIRMING OR SUPPORTING MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT REPORTED. BASED ON THE VERBIAGE IN THE CUSTOMER COMPLAINT, IT IS NOTED THAT THE FAILURE WAS POTENTIALLY USER ERROR.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A SAMPLE HAS BEEN RECEIVED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHLEBOTOMIST WAS STUCK WITH THE NEEDLE OF THE SUSPECT DEVICE. IT WAS NOTED THAT, THE PHLEBOTOMIST USED HIS/HER THUMB TO PUSH THE BUTTON AND NOTED HIS/HER "FINGER GETS IN THE WAY OF THE PIECE THAT EXISTS FROM THE BACK OF THE NEEDLE STOPPING THE NEEDLE FROM RETRACTING." THE SOURCE PATIENT NOT KNOWN TO HAVE AN INFECTIOUS DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742775 21GX.75" BD VACUTAINER® WINGED SAFETY PBBCS, 12" TUBING, LUER ADAPTER BLOOD COLLECTION SET JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6236616

    Patients

    Seq Age Sex Outcome Treatment
    1 Other