BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    MDR report key: 9233874 · Received October 24, 2019

    Report

    Report Number
    1024879-2019-01854
    Event Type
    Malfunction
    Date Received
    October 24, 2019
    Date of Event
    October 4, 2019
    Report Date
    January 29, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686563
    PMA / PMN Number
    K011984
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. DATE RECEIVED BY MANUFACTURER: 2019-10-11.

    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 LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND LEAKAGE 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. 368656, MATERIAL NO. 9150607. IT IS REPORTED THAT DURING USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPLATTER WAS INSIDE HOLDER AND LEAKAGE WAS WITNESSED UNDER BLUE WINGS AFTER BLOOD DRAW WAS COMPLETE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A DROP OF BLOOD WAS NOTICED ON THE HUB WHILE BEING USED. AND WHEN THE NEEDLE WAS TOOK OUT, BLOOD WAS ALSO NOTICED UNDER THE WINGS."

    Description of Event or Problem · 0

    MATERIAL NO. 368656, MATERIAL NO. 9150607 IT IS REPORTED THAT DURING USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPLATTER WAS INSIDE HOLDER AND LEAKAGE WAS WITNESSED UNDER BLUE WINGS AFTER BLOOD DRAW WAS COMPLETE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A DROP OF BLOOD WAS NOTICED ON THE HUB WHILE BEING USED. AND WHEN THE NEEDLE WAS TOOK OUT, BLOOD WAS ALSO NOTICED UNDER THE WINGS."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE: FMI/JKA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 368656, MATERIAL NO. 9150607. IT IS REPORTED THAT DURING USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPLATTER WAS INSIDE HOLDER AND LEAKAGE WAS WITNESSED UNDER BLUE WINGS AFTER BLOOD DRAW WAS COMPLETE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A DROP OF BLOOD WAS NOTICED ON THE HUB WHILE BEING USED. AND WHEN THE NEEDLE WAS TOOK OUT, BLOOD WAS ALSO NOTICED UNDER THE WINGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030663 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER BLOOD SPECIMEN COLLECTION DEVICE FMI BECTON, DICKINSON & CO., (BD) 368656 9150607 50382903686563

    Patients

    Seq Age Sex Outcome Treatment
    1 Other