BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    MDR report key: 10667518 · Received October 12, 2020

    Report

    Report Number
    1917413-2020-00926
    Event Type
    Malfunction
    Date Received
    October 12, 2020
    Date of Event
    September 22, 2020
    Report Date
    October 28, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678612
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-10-22. INVESTIGATION SUMMARY: BD RECEIVED 100 SAMPLES AND 1 PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 10 CUSTOMER SAMPLES ALONG WITH 10 RETENTION SAMPLES 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES HAD UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED THERE WAS "UNDERFILLING OF 367861 EDTA 4ML TUBES HPD CHIEF MEDICAL TECHNOLOGIST REPORTED ANOTHER UNDERFILLING INCIDENT WITH A DIFFERENT PHLEBOTOMIST (#2). PHLEBOTOMIST #2 USED THE EDTA 4ML VIA CLOSED SYSTEM COLLECTION AND OBSERVED THE SAME UNDERFILLING OBSERVED IN PREVIOUS DAY.¿

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES HAD UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED THERE WAS "UNDERFILLING OF 367861 EDTA 4ML TUBES HPD CHIEF MEDICAL TECHNOLOGIST REPORTED ANOTHER UNDERFILLING INCIDENT WITH A DIFFERENT PHLEBOTOMIST (#2). PHLEBOTOMIST #2 USED THE EDTA 4ML VIA CLOSED SYSTEM COLLECTION AND OBSERVED THE SAME UNDERFILLING OBSERVED IN PREVIOUS DAY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131595 BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367861 9184930 50382903678612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other