BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SERUM BLOOD COLLECTION TUBES

    MDR report key: 11733490 · Received April 27, 2021

    Report

    Report Number
    1917413-2021-00332
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 27, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903664301
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 1014054 D.4. MEDICAL DEVICE EXPIRATION DATE: 1/31/2023 H.4. DEVICE MANUFACTURE DATE: 1/14/2021 H.6. INVESTIGATION: BD RECEIVED (B)(4) SAMPLES AND NO PHOTOS FOR INVESTIGATION. THE SAMPLES AND RETENTION SAMPLES WERE EVALUATED VISUALLY WITH NO ISSUES BEING IDENTIFIED. 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. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SERUM BLOOD COLLECTION TUBES WAS MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 366430, BATCH NO. UNKNOWN IT IS REPORTED TUBES ARE NOT MIXING BLOOD PROPERLY. VERBIAGE RECEIVED, - "THESE VACUTAINERS ARE NOT WORKING PROPERLY. THEY ARE NOT MIXING THE BLOOD PROPERLY WITH THIS RECENT BATCH.""

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INITIAL REPORTER FACILITY NAME: (B)(6). INVESTIGATION SUMMARY: 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SERUM BLOOD COLLECTION TUBES WAS MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 366430, BATCH NO. UNKNOWN IT IS REPORTED TUBES ARE NOT MIXING BLOOD PROPERLY. VERBIAGE RECEIVED, - "THESE VACUTAINERS ARE NOT WORKING PROPERLY. THEY ARE NOT MIXING THE BLOOD PROPERLY WITH THIS RECENT BATCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627597 BD VACUTAINER SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 366430 1014054 50382903664301

    Patients

    Seq Age Sex Outcome Treatment
    1