BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 8897215 · Received August 15, 2019

    Report

    Report Number
    1024879-2019-01442
    Event Type
    Injury
    Date Received
    August 15, 2019
    Date of Event
    July 25, 2019
    Report Date
    September 26, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR INCOMPLETE RETRACTION WITH THE INCIDENT LOT WAS OBSERVED. AS THE SAMPLE RETURNED WAS CONTAMINATED, FURTHER ANALYSIS OF THE SAMPLE WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    MATERIAL NO. 367342 BATCH NO. 9042605. IT WAS REPORTED THAT AFTER USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET AS THE NURSE WAS GATHERING UP THE SUPPLIES HE USED WHEN HE PICKED UP THE BLOOD COLLECTION SET THE NEEDLE RE-ENGAGED AND THE NEEDLE STUCK OUT THE FRONT END OF THE DEVICE STRIKING THE NURSE. AFTER THE NEEDLE STICK THE HOSPITAL PROTOCOL FOR SHARPS INCIDENTS WITH BLOOD EXPOSURE WAS STARTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER NURSE COMPLETED A BLOOD COLLECTION ON A PATIENT, WHEN HE GRABBED THE WING SET, THE BLOODY NEEDLE UNLOCKED, CAME OUT OF THE HUB AND STUCK HIM. A NURSE PREFORMED A BLOOD DRAW ON A PATIENT AND WHEN THE RETRACTION MECHANISM WAS ACTIVATED ( THE BUTTON WAS PUSHED AND THE NEEDLE RETRACTED), HE PROCEEDED TO PICK UP HIS SUPPLIES. WHEN HE GATHERED HIS CONSUMABLES (INCLUDING THE PUSH BUTTON WING SET), THE WING SET NEEDLE RE-ENGAGED, CAME OUT OF THE FRONT END OF THE DEVICE AND CAUSED AN ACCIDENTAL NEEDLE STICK/BLOOD EXPOSURE TO THE SAID NURSE. THE HOSPITAL PROTOCOL FOR SHARPS INCIDENTS WITH BLOOD EXPOSURE WAS STARTED."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 367342, BATCH NO. 9042605. IT WAS REPORTED THAT AFTER USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET AS THE NURSE WAS GATHERING UP THE SUPPLIES HE USED WHEN HE PICKED UP THE BLOOD COLLECTION SET THE NEEDLE RE-ENGAGED AND THE NEEDLE STUCK OUT THE FRONT END OF THE DEVICE STRIKING THE NURSE. AFTER THE NEEDLE STICK THE HOSPITAL PROTOCOL FOR SHARPS INCIDENTS WITH BLOOD EXPOSURE WAS STARTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER NURSE COMPLETED A BLOOD COLLECTION ON A PATIENT, WHEN HE GRABBED THE WING SET, THE BLOODY NEEDLE UNLOCKED, CAME OUT OF THE HUB AND STUCK HIM. A NURSE PREFORMED A BLOOD DRAW ON A PATIENT AND WHEN THE RETRACTION MECHANISM WAS ACTIVATED (THE BUTTON WAS PUSHED AND THE NEEDLE RETRACTED), HE PROCEEDED TO PICK UP HIS SUPPLIES. WHEN HE GATHERED HIS CONSUMABLES (INCLUDING THE PUSH BUTTON WING SET), THE WING SET NEEDLE RE-ENGAGED, CAME OUT OF THE FRONT END OF THE DEVICE AND CAUSED AN ACCIDENTAL NEEDLE STICK/BLOOD EXPOSURE TO THE SAID NURSE. THE HOSPITAL PROTOCOL FOR SHARPS INCIDENTS WITH BLOOD EXPOSURE WAS STARTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692334 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9042605 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention