BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2E 7.2MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 11113783 · Received January 4, 2021

    Report

    Report Number
    9617032-2020-01095
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Date of Event
    December 9, 2020
    Report Date
    May 26, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED 3 PHOTOGRAPHS WERE ATTACHED, SHOWING CLUMPS OF NEUTROPHILS THROUGH THE MICROSCOPE. 40 RETAINED TUBES WERE ANALYZED FOR THE EDTA CONTENT FROM AND WERE ALL WITHIN SPEC LIMITS. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE RETAINED SAMPLES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERRONEOUS RESULTS WERE FOUND WHILE USING BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE BEEN MADE AWARE THAT THERE HAVE BEEN SOME ANECDOTAL REPORTS OF NEUTROPHIL AGGREGATION ASSOCIATED WITH SOME LOT NUMBERS OF BD VACUTAINERS, THOUGH THE EVIDENCE SEEMS TO BE A LITTLE ANECDOTAL AT THE MOMENT. I UNDERSTAND THAT THIS CAN RESULT IN A HIGH IMMATURE GRANULOCYTE COUNT AT FIRST PRESENTATION TO ANALYSERS - WHICH MAY RESOLVE WITH WARMING. DO YOU HAVE ANY INFORMATION ON THIS , WHETHER THERE IS ANY SUBSTANCE TO THE REPORTS / ONGOING INVESTIGATION?"

    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 #: 0007415, MEDICAL DEVICE EXPIRATION DATE: 2021-05-31, DEVICE MANUFACTURE DATE: 2020-01-07; MEDICAL DEVICE LOT #: 0112585, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: 2020-04-21. INITIAL REPORTER PHONE#: (B)(6). 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 THAT ERRONEOUS RESULTS WERE FOUND WHILE USING BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE BEEN MADE AWARE THAT THERE HAVE BEEN SOME ANECDOTAL REPORTS OF NEUTROPHIL AGGREGATION ASSOCIATED WITH SOME LOT NUMBERS OF BD VACUTAINERS, THOUGH THE EVIDENCE SEEMS TO BE A LITTLE ANECDOTAL AT THE MOMENT. I UNDERSTAND THAT THIS CAN RESULT IN A HIGH IMMATURE GRANULOCYTE COUNT AT FIRST PRESENTATION TO ANALYSERS - WHICH MAY RESOLVE WITH WARMING. DO YOU HAVE ANY INFORMATION ON THIS , WHETHER THERE IS ANY SUBSTANCE TO THE REPORTS / ONGOING INVESTIGATION?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4201 BD VACUTAINER K2E 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 0112585

    Patients

    Seq Age Sex Outcome Treatment
    1