BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

    MDR report key: 12497976 · Received September 20, 2021

    Report

    Report Number
    1917413-2021-00821
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    August 24, 2021
    Report Date
    September 20, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678568
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES OF EACH LOT FROM BD INVENTORY WERE EVALUATED BY DRAW TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE UNDERRFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE HAVE RECENTLY BEEN HAVING PROBLEMS WITH EDTA TUBES NOT PULLING THE CORRECT AMOUNT WHEN DRAWING BLOOD WITH BOTH A VACUTAINER AND USING A SYRINGE. LOT NUMBER 0100261 EXPIRATION DATE: 8-31-2021 3ML EDTA WAS ONLY DRAWING 2ML INTO THE TUBE. LOT NUMBER 0258318 EXPIRATION DATE: 01-31-2022 3ML EDTA WAS DRAWING 2.5ML INTO THE TUBE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0100261. MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2020-04-09. MEDICAL DEVICE LOT #: 0258318. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. DEVICE MANUFACTURE DATE: 2020-09-14. 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 WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE HAVE RECENTLY BEEN HAVING PROBLEMS WITH EDTA TUBES NOT PULLING THE CORRECT AMOUNT WHEN DRAWING BLOOD WITH BOTH A VACUTAINER AND USING A SYRINGE. LOT NUMBER 0100261 EXP. 8-31-2021 3ML EDTA WAS ONLY DRAWING 2ML INTO THE TUBE. LOT NUMBER 0258318 EXP. 01-31-2022 3ML EDTA WAS DRAWING 2.5ML INTO THE TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1393287 BD VACUTAINER K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367856 SEE H.10 50382903678568

    Patients

    Seq Age Sex Outcome Treatment
    1