BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 11322940 · Received February 12, 2021

    Report

    Report Number
    9617032-2021-00127
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    January 23, 2021
    Report Date
    April 26, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/11/2021. H.6. INVESTIGATION:BD RECEIVED SAMPLES FOR INVESTIGATION. HOWEVER, RETENTION SAMPLES WERE EVALUATED AS THE RETURNED SAMPLES WERE SENT TO FRANKLIN LAKES AND THE TESTING WAS PERFORMED IN PLYMOUTH. THEREFORE, RETENTION SAMPLES FROM BD INVENTORY FROM EACH LOT WERE DRAWN WITH HORSE BLOOD, MIXED, STOOD AT ROOM TEMPERATURE FOR 30 MINUTES, BEFORE BEING CENTRIFUGED AT 3450 RPM FOR 10 MINUTES, USING AN MSE MISTRAL 1000 CENTRIFUGE. THE SUPERNATANTS WERE THEN DECANTED AND EXAMINED UNDER MAGNIFICATION FOR ANY SIGNS OF GEL GLOBULES. 3 (LOT 0240236 - 1 AND LOT 9304068 ¿ 2) OUT OF 8 TUBES PRODUCED GLOBULES. 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 HAS BEEN CONFIRMED FOR GEL GLOBULES. A ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS OIL GEL GLOBULES. THIS EVENT OCCURRED 15000 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "GEL GLOBULES ARE FOUND IN SST-II ADVANCE TUBE DUE TO WHICH ANALYSIS COULDN'T BE PERFORMED IN BIOCHEMISTRY LAB AND REPEAT SPECIMEN IS COLLECTED FROM PATIENT. BECAUSE OF THIS INCIDENT TURN AROUND TIME AND MAINTENANCE HAS INCREASED AND REAGENT ARE WASTED. AFTER CHANGE OF PROBE STILL FACING GEL GLOBULES."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0240236, MEDICAL DEVICE EXPIRATION DATE: 2022-02-28, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 9304068, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: (B)(6) 2019. 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 WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS OIL GEL GLOBULES. THIS EVENT OCCURRED 15000 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "GEL GLOBULES ARE FOUND IN SST-II ADVANCE TUBE DUE TO WHICH ANALYSIS COULDN'T BE PERFORMED IN BIOCHEMISTRY LAB AND REPEAT SPECIMEN IS COLLECTED FROM PATIENT. BECAUSE OF THIS INCIDENT TURN AROUND TIME AND MAINTENANCE HAS INCREASED AND REAGENT ARE WASTED. AFTER CHANGE OF PROBE STILL FACING GEL GLOBULES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222025 BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1