BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 12021368 · Received June 17, 2021

    Report

    Report Number
    1024879-2021-00401
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 24, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673242
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED 2 CUSTOMER SAMPLES FROM LOT 1082822 AND 4 CUSTOMER SAMPLES FROM LOT 1082721 AND 2 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR BARREL SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH 100 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE ISSUE OF BARREL SEPARATION WAS OBSERVED. BASED ON A REVIEW OF BATCH RECORDS, NO ROOT CAUSE FROM MANUFACTURING WAS IDENTIFIED AS A CONTRIBUTOR. BD IDENTIFIED TWO ROOT CAUSES FOR THE INDICATED FAILURE MODE AND THEY BEEN IDENTIFIED TO BE WITHIN THE ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BEFORE USE, THE STAFF WAS ATTEMPTING TO SET UP THE PRODUCT FOR USE. DURING HANDLING THE BARREL SEPARATED. NO HARM OR NEEDLE STICK OCCURRED." THIS IS REPORT (1 OF 2).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0027015, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 1082721, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2021-03-23. MEDICAL DEVICE LOT #: 1082822, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2021-03-23. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET, MEDICAL DEVICE TYPE: FPA. 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

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BEFORE USE, THE STAFF WAS ATTEMPTING TO SET UP THE PRODUCT FOR USE. DURING HANDLING THE BARREL SEPARATED. NO HARM OR NEEDLE STICK OCCURRED." THIS IS REPORT (1 OF 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916821 BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367324 SEE H.10 50382903673242

    Patients

    Seq Age Sex Outcome Treatment
    1