BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 15750051 · Received November 7, 2022

    Report

    Report Number
    1024879-2022-00654
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Date of Event
    October 12, 2022
    Report Date
    December 19, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673440
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ANNEX B: B21; ANNEX C: C21; ANNEX D: D16. ANNEX A: AA0404, A0801, A1801, A040506; ANNEX G: G04088, G04090, G02017, G04067, G04037, G0204002; ANNEX B: B01; ANNEX C: C07, C1302, C0601, C070606; ANNEX D: D15, D02. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET IT WAS DIFFICULT/UNABLE TO PIERCE THROUGH STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE NEEDLE IS NOT PUNCTURING THROUGH THE TUBE." CUSTOMER HAD TO INCREASE SIGNIFICANT PRESSURE IN ORDER TO PUNCTURE THEM IN RECENT WEEKS WHEN USING PRODUCT 367344, LOT 2251466.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET IT WAS DIFFICULT/UNABLE TO PIERCE THROUGH STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE NEEDLE IS NOT PUNCTURING THROUGH THE TUBE." CUSTOMER HAD TO INCREASE SIGNIFICANT PRESSURE IN ORDER TO PUNCTURE THEM IN RECENT WEEKS WHEN USING PRODUCT 367344, LOT 2251466.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250566 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367344 2251466 50382903673440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown