BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9140787 · Received October 1, 2019

    Report

    Report Number
    1024879-2019-01729
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 16, 2019
    Report Date
    October 8, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679831
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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. ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION RELATING TO LABEL LIFT THROUGH CAPA#106441. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES LABELS ARE LIFTING UP FROM THE TUBES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367983, BATCH NO. 9030743 AND 9018759 -IT IS REPORTED LABELS ARE LIFTING UP FROM TUBES. VERBIAGE RECEIVED VIA EMAIL, - "WE¿VE NOTICED THAT A LOT OF THE VACUTAINER BLOOD COLLECTION TUBES WE¿VE BEEN USING HAVE HAD THE LABEL PEELING OFF FROM THE SIDES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9030743. MEDICAL DEVICE EXPIRATION DATE: 2020-01-31. DEVICE MANUFACTURE DATE: 2019-01-30. MEDICAL DEVICE LOT #: 9018759. MEDICAL DEVICE EXPIRATION DATE: 2020-01-31. DEVICE MANUFACTURE DATE: 2019-01-18. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES LABELS ARE LIFTING UP FROM THE TUBES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367983, BATCH NO. 9030743 AND 9018759. IT IS REPORTED LABELS ARE LIFTING UP FROM TUBES. VERBIAGE RECEIVED VIA EMAIL, "WE¿VE NOTICED THAT A LOT OF THE VACUTAINER BLOOD COLLECTION TUBES WE¿VE BEEN USING HAVE HAD THE LABEL PEELING OFF FROM THE SIDES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937508 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10 50382903679831

    Patients

    Seq Age Sex Outcome Treatment
    1 Other