BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES

    MDR report key: 18351200 · Received December 18, 2023

    Report

    Report Number
    9617032-2023-01815
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    November 23, 2023
    Report Date
    January 9, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630955
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 9617032-2023-01815 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INFORMATION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3180412 D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2024 H4. DEVICE MANUFACTURE DATE: 29-JUN-2023 D4. MEDICAL DEVICE LOT #: 3227387 D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2024 H4. DEVICE MANUFACTURE DATE: 15-AUG-2023 D4. MEDICAL DEVICE LOT #: 3247744 D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024 H4. DEVICE MANUFACTURE DATE: 04-SEP-2023 D4. MEDICAL DEVICE LOT #: 3226441 D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2024 H4. DEVICE MANUFACTURE DATE: 15-AUG-2023 D4. MEDICAL DEVICE LOT #: 3261566 D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024 H4. DEVICE MANUFACTURE DATE: 18-SEP-2023 (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES, TUBES ARE OVERFILLING. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES, TUBES ARE OVERFILLING. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920173 BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H10 50382903630955

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown