BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 18722775 · Received February 16, 2024

    Report

    Report Number
    9617032-2024-00206
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    November 6, 2023
    Report Date
    February 9, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FPA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A. COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET D2B. MEDICAL DEVICE TYPE: JKA D4. MEDICAL DEVICE LOT#: UNKNOWN D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.5. PMA / 510(K)#: K220212 H4. DEVICE MANUFACTURE DATE: UNKNOWN. H.6. INVESTIGATION SUMMARY: MATERIAL #: 367342 LOT/BATCH #: UNKNOWN BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE USER IS REMOVING THE NON-PATIENT CANNULA END OF THE DEVICE AND PLACING IT IN A TRAY WITH OTHER USED BLOOD COLLECTION DEVICES. WHEN DISCARDING THE REMOVED COMPONENT A NEEDLESTICK INJURY OCCURRED. NO MEDICAL TREATMENT OR INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431276 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SEE H.10 FPA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other