BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 8016134 · Received October 29, 2018

    Report

    Report Number
    1024879-2018-01323
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 8, 2018
    Report Date
    November 5, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903678204
    PMA / PMN Number
    K960250
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR ADDITIVE ABNORMALITY WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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. BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR ADDITIVE ABNORMALITY WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8082679, MEDICAL DEVICE EXPIRATION DATE: 2020-03-31, DEVICE MANUFACTURE DATE: 2018-03-23. MEDICAL DEVICE LOT #: 7033966, MEDICAL DEVICE EXPIRATION DATE: 2019-02-28, DEVICE MANUFACTURE DATE: 2017-02-02. MEDICAL DEVICE LOT #: 7033973, MEDICAL DEVICE EXPIRATION DATE: 2019-01-31, DEVICE MANUFACTURE DATE: 2017-02-02. MEDICAL DEVICE LOT #: 7291875, MEDICAL DEVICE EXPIRATION DATE: 2019-10-31, DEVICE MANUFACTURE DATE: 2017-10-18.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER SERUM BLOOD COLLECTION TUBES HAVE STREAKS AND SMEARS OF SILICA THAT CONGREGATED INTO LARGE DROPLETS. THEY ARE CONCERNED THIS CONDITION COULD LEAD TO ERRONEOUS RESULTS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SERUM BLOOD COLLECTION TUBES HAVE STREAKS AND SMEARS OF SILICA THAT CONGREGATED INTO LARGE DROPLETS. THEY ARE CONCERNED THIS CONDITION COULD LEAD TO ERRONEOUS RESULTS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT BD VACUTAINER® SERUM BLOOD COLLECTION TUBES HAVE STREAKS AND SMEARS OF SILICA THAT CONGREGATED INTO LARGE DROPLETS. THEY ARE CONCERNED THIS CONDITION COULD LEAD TO ERRONEOUS RESULTS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857037 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10. 00382903678204

    Patients

    Seq Age Sex Outcome Treatment
    1 Other