BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 9564273 · Received January 8, 2020

    Report

    Report Number
    1024879-2019-02238
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Date of Event
    December 20, 2019
    Report Date
    January 28, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678124
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR MISSING LABEL WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH PRODUCT MISSING LABELING. 400 TUBES HAD THIS ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT WAS FOUND DURING LABELING PROCESS MISSING LABEL. WHEN WE OPEN THE CARTON AND REMOVE THE PRODUCT FROM THE CARTON, WE FOUND THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES (MISSING LABEL).

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9170888. MEDICAL DEVICE EXPIRATION DATE: 2020-10-31. DEVICE MANUFACTURE DATE: 2019-06-19. MEDICAL DEVICE LOT #: 9165865. MEDICAL DEVICE EXPIRATION DATE: 2020-10-31 . DEVICE MANUFACTURE DATE: 2019-06-14. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH PRODUCT MISSING LABELING. 400 TUBES HAD THIS ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT WAS FOUND DURING LABELING PROCESS MISSING LABEL. WHEN WE OPEN THE CARTON AND REMOVE THE PRODUCT FROM THE CARTON, WE FOUND THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES (MISSING LABEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30110 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367812 SEE SECTION H.10 50382903678124

    Patients

    Seq Age Sex Outcome Treatment
    1 Other