BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES

    MDR report key: 8061335 · Received November 12, 2018

    Report

    Report Number
    9617032-2018-03078
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Date of Event
    November 6, 2018
    Report Date
    November 30, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    GIM
    UDI-DI
    50382903688611
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 ADDITIVE ABNORMALITY 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. BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR ADDITIVE ABNORMALITY WITH THE INCIDENT LOT WAS OBSERVED. BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER K2E (EDTA) PLUS BLOOD COLLECTION TUBES CONTAINED FOREIGN MATTER OR HAD ADDITIVE ABNORMALITY. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 #: 8242915. MEDICAL DEVICE EXPIRATION DATE: 2019-12-31. DEVICE MANUFACTURE DATE: 2018-08-30. MEDICAL DEVICE LOT #: 8242917. MEDICAL DEVICE EXPIRATION DATE: 2020-01-31. DEVICE MANUFACTURE DATE: 2018-08-30. MEDICAL DEVICE LOT #: 8256511. MEDICAL DEVICE EXPIRATION DATE: 2020-01-31. DEVICE MANUFACTURE DATE: 2018-09-13. (B)(6). 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® K2E (EDTA) PLUS BLOOD COLLECTION TUBES CONTAINED FOREIGN MATTER OR HAD ADDITIVE ABNORMALITY. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902187 BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE GIM BECTON, DICKINSON AND COMPANY (BD) SEE H.10 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other