BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES

    MDR report key: 18170142 · Received November 20, 2023

    Report

    Report Number
    9617032-2023-01665
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    August 21, 2023
    Report Date
    November 22, 2023
    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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 363095. LOT/BATCH #: 3030792. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THE EXPIRY DATE OF THE LOT NUMBER INVOLVED WAS 31TH OCTOBER 2023. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE VIA RETENTION TESTING BECAUSE THE TUBES HAS EXPIRED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    H3. 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 · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES INSUFFICIENT NEGATIVE PRESSURE WAS FOUND DURING USE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES INSUFFICIENT NEGATIVE PRESSURE WAS FOUND DURING USE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796190 BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3030792 50382903630955

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown