BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES

    MDR report key: 18351221 · Received December 18, 2023

    Report

    Report Number
    9617032-2023-01816
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    November 23, 2023
    Report Date
    November 27, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1. INITIAL REPORTER PHONE #: (B)(6). H6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 20 RETENTION SAMPLES OF EACH LOT FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO OVERFILL AS ALL SAMPLES MET SPECIFICATIONS. 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 OVERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78152 BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3226441 50382903630955

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown