BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES

    MDR report key: 12186228 · Received July 17, 2021

    Report

    Report Number
    1917413-2021-00637
    Event Type
    Malfunction
    Date Received
    July 17, 2021
    Date of Event
    June 28, 2021
    Report Date
    August 2, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678414
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : BD HAD NOT RECEIVED SAMPLES, BUT ONE PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR ADDITIVE ABNORMALITY WITH THE INCIDENT LOT WAS NOT OBSERVED. THE ADDITIVE IS SPRAYED ONTO THE INSIDE WALL OF THE TUBE WITH THE HEAVIER PATTERN BEING AT THE TOP. THERE ARE NO LARGE DROPLETS OR NO RUN-DOWN PATTERN ON THE WALL OF THE TUBE. THIS IS THE NORMAL APPEARANCE OF THE SPRAY COAT PATTERN FOR CATALOG 367841. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO ADDITIVE ABNORMALITY 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 ADDITIVE ABNORMALITY. 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) 3.6MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED DISCOLORED / ABNORMAL ADDITIVE FORM . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THERE IS WATER DROPLETS INSIDE THE TUBES. I HAD TWO LOT#S BELOW FOR BD#367841 THAT HAD WATER DROPLETS INSIDE THE BD#367841 TUBE. THE INNER WALL OF THIS VACUTAINER IS COATED WITH SPRAY-DRIED K2EDTA.

    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 #: 0100253. MEDICAL DEVICE EXPIRATION DATE: 2021-07-31. DEVICE MANUFACTURE DATE: 2020-04-09. MEDICAL DEVICE LOT #: 0316336. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2020-11-11. 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) 3.6MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED DISCOLORED / ABNORMAL ADDITIVE FORM . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THERE IS WATER DROPLETS INSIDE THE TUBES. I HAD TWO LOT#S BELOW FOR BD#367841 THAT HAD WATER DROPLETS INSIDE THE BD#367841 TUBE. THE INNER WALL OF THIS VACUTAINER IS COATED WITH SPRAY-DRIED K2EDTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083113 BD VACUTAINER K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367841 SEE H.10. 50382903678414

    Patients

    Seq Age Sex Outcome Treatment
    1