BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 9321546 · Received November 14, 2019

    Report

    Report Number
    1024879-2019-01973
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 7, 2019
    Report Date
    February 3, 2020
    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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR BARREL SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND BARREL SEPARATION WAS NOT OBSERVED. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO. 367342; BATCH NO. 9161894. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WHILE RETRACTING THE NEEDLE, THE DEVICE SEPARATED AND THE NEEDLE FELL ON THE FLOOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A REPORT OF A PRODUCT DEVICE FAILURE FOR A SPECIFIC LOT OF BD VACUTAINER BUTTERFLY BLOOD COLLECTION SETS PART #367342 FROM ONE OF OUR LAB TESTING LOCATIONS. UPON RETRACTING THE NEEDLE THE DEVICE DISLODGED COMPLETELY AND THE NEEDLE FELL ON TO THE FLOOR.

    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. 9161894. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WHILE RETRACTING THE NEEDLE, THE DEVICE SEPARATED AND THE NEEDLE FELL ON THE FLOOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A REPORT OF A PRODUCT DEVICE FAILURE FOR A SPECIFIC LOT OF BD VACUTAINER BUTTERFLY BLOOD COLLECTION SETS PART #367342 FROM ONE OF OUR LAB TESTING LOCATIONS. UPON RETRACTING THE NEEDLE THE DEVICE DISLODGED COMPLETELY AND THE NEEDLE FELL ON TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114186 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET JKA BECTON, DICKINSON & CO., (BD) 367342 9161894 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other