BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBE

    MDR report key: 15777776 · Received November 11, 2022

    Report

    Report Number
    9617032-2022-01131
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    October 25, 2022
    Report Date
    October 27, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 #: 2112313, MEDICAL DEVICE EXPIRATION DATE: 2023-08-31, DEVICE MANUFACTURE DATE: 2022-04-22. MEDICAL DEVICE LOT #: 2145930, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: 2022-05-25. INVESTIGATION SUMMARY: BD RECEIVED 2 PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. AN EVALUATION OF THE PHOTOS WAS CONDUCTED AND THE ISSUE UNDERFILL WAS OBSERVED. ADDITIONALLY, 20 RETAINED SAMPLES FROM EACH LOT OF THE BD INVENTORY WERE FUNCTIONALLY TESTED AND THE ISSUE OF UNDERFILL WAS NOT OBSERVED. FROM THIS TESTING, IT WAS DETERMINED THAT ALL 40 TUBES DREW WITHIN SPECIFICATION. BD WAS ABLE TO CONFIRM CUSTOMERS¿ INDICATED FAILURE MODE BASED ON PHOTOGRAPHS PROVIDED. ALTHOUGH PHOTOGRAPHS PROVIDED BY THE CUSTOMER DO INDICATE A LACK OF DRAW, THERE IS NO EVIDENCE THAT THE DEVICE WAS THE CAUSE OF THIS DEFECT AS TESTING OF RETAINED SAMPLES FROM THIS LOT NUMBER DID NOT CONFIRM THE REPORTED DEFECT. BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 8 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: TH "K2EDTA TUBE PROVIDED UNDERFILL VOLUME OF A SPECIMEN AND LOW EVACUATE PRESSURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516261 BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown