BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES

    MDR report key: 8488233 · Received April 5, 2019

    Report

    Report Number
    9617032-2019-00396
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 18, 2019
    Report Date
    March 26, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903688611
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8295713; MEDICAL DEVICE EXPIRATION DATE: 2020-02-29; DEVICE MANUFACTURE DATE: 2018-10-22. MEDICAL DEVICE LOT #: 8040575; MEDICAL DEVICE EXPIRATION DATE: 2019-06-30; DEVICE MANUFACTURE DATE: 2018-02-09. (B)(6). INVESTIGATION SUMMARY: 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 WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND TESTING AND UPON COMPLETION, THE ISSUE WAS NOT 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE RETAIN SAMPLES WAS CONDUCTED AND THE DEFECT COULD NOT BE REPLICATED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED FROM THE PHOTO AND COULD NOT BE REPLICATED USING BD SINGLE USE HOLDER AND MULTI SAMPLE NEEDLE. RATIONALE: 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 · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES HAD AIR BUBBLES IN THEM AFTER SAMPLE COLLECTION, AND SUBSEQUENT BUBBLES FORMED IN MANY AFTER ANALYSIS. LOT # 8295713 WAS REPORTED TO HAVE HAD 100 OCCURRENCES OF THE EVENT, AND LOT # 8040575 WAS REPORTED TO HAVE HAD AN UNKNOWN NUMBER OF OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "SIGNIFICANT PRESENCE OF FOAM IN THE EDTA TUBES IMMEDIATELY AFTER SAMPLING AND SEVERAL SUBSEQUENT ONES EVEN AFTER ANALYSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282751 BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE SECTION H.10. 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other