BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12123263 · Received July 6, 2021

    Report

    Report Number
    9617032-2021-00712
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 4, 2021
    Report Date
    August 2, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903688611
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: 2021-07-28. H6: INVESTIGATION SUMMARY: BD RECEIVED 6 SAMPLES OF LOT: 1022411 FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY DRAW TESTING AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 20 RETENTION SAMPLES FROM EACH LOT( LOT: 1022411, LOT: 1004559 ) FROM BD INVENTORY WERE EVALUATED BY DRAW WATER TESTING AND THE ISSUE RELATING TO UNDERFILL WAS NOT OBSERVED. FROM THIS TESTING IT WAS DETERMINED THAT ALL 46 TUBES DREW WITHIN SPECIFICATION. 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. 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® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED FOUR TIMES WITH LOT 1022411. .THIS EVENT OCCURRED FOUR TIMES WITH LOT 1004559. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DURING A BLOOD TEST, THE PURPLE TUBE FILLS CORRECTLY THEN STOPS FILLING AT ONCE, TRY ANOTHER PURPLE TUBE: IDEM THEN A GREY TUBE WHICH FILLS NORMALLY THEN AGAIN 2 PURPLE TUBES WHICH DO NOT FILL WELL AGAIN. IMPRESSION THAT THE PURPLE TUBES LACK VACUUM.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1022411. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2021-01-04. MEDICAL DEVICE LOT #: 1004559. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2021-01-22. " 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® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED FOUR TIMES WITH LOT 1022411. THIS EVENT OCCURRED FOUR TIMES WITH LOT 1004559. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DURING A BLOOD TEST, THE PURPLE TUBE FILLS CORRECTLY THEN STOPS FILLING AT ONCE, TRY ANOTHER PURPLE TUBE: IDEM THEN A GREY TUBE WHICH FILLS NORMALLY THEN AGAIN 2 PURPLE TUBES WHICH DO NOT FILL WELL AGAIN. IMPRESSION THAT THE PURPLE TUBES LACK VACUUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020857 BD VACUTAINER K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 368861 1004559 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1