BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER LH PST II PLUS BLOOD COLLECTION TUBES

    MDR report key: 12123146 · Received July 6, 2021

    Report

    Report Number
    9617032-2021-00711
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 10, 2021
    Report Date
    August 30, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    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 CORRECTIONS: MDR OWNERSHIP: (POOR BARRIER SEPARATION OF SAMPLE AND AIR BUBBLES IN GEL). H.6. INVESTIGATION SUMMARY: BD RECEIVED 3 SAMPLES AND 3 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR GEL SMEARING WAS OBSERVED. THE CUSTOMER SAMPLES WERE DRAWN WITH HORSE BLOOD, MIXED, CENTRIFUGED AT 1300G FOR 10 MINUTES, USING AN MSE MISTRAL 1000 CENTRIFUGE. ALL 3 TUBES WERE FOUND TO HAVE GOOD GEL SEPARATION. NO GEL SMEARING WERE OBSERVED ON THE RETURNED SAMPLES. ADDITIONALLY, RETENTION SAMPLES FROM EACH LOT NUMBER: 1033164, 1076056,1053915 WERE DRAWN WITH HORSE BLOOD, MIXED, STOOD AT ROOM TEMPERATURE FOR 30 MINUTES, BEFORE BEING CENTRIFUGED AT 1300G FOR 10 MINUTES, USING AN MSE MISTRAL 1000 CENTRIFUGE. ALL TUBES FOR LOT#'S 1033164, 1076056 WERE FOUND TO HAVE GOOD GEL SEPARATION. NO GEL SMEARING WAS OBSERVED. FOR LOT 105391, 1 OUT OF 4 TUBES TESTED HAD SLIGHT SMEARS OF GEL ABOVE THE BARRIER ON ITS WALL. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE OF GEL SMEARING BASED ON THE PHOTOS PROVIDED AND THE RETAINED SAMPLES TESTING FOR LOT 1053915. RETENTION SAMPLE TESTING OF LOTS 1033164 AND 1076056 WAS SATISFACTORY. TESTING OF RETURNED SAMPLES WAS SATISFACTORY. 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 THE INDICATED FAILURE MODE GEL SMEARING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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® LH PST¿ II PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED POOR BARRIER SEPARATION OF SAMPLE AND AIR BUBBLES IN GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: INDEED, THE TWO PHASES IN THE GEL TUBE DO NOT SEPARATE CLEARLY + PRESENCE OF BUBBLES ON THE SURFACE + DEPOSIT OF GEL WITH PRESENCE OF BLOOD ON THE WALLS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1033164. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2021-02-02. MEDICAL DEVICE LOT #: 1053915. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2021-02-22. MEDICAL DEVICE LOT #: 1076056. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. DEVICE MANUFACTURE DATE: 2021-03-17". 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® LH PST¿ II PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED POOR BARRIER SEPARATION OF SAMPLE , FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL, AND AIR BUBBLES IN GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: INDEED, THE TWO PHASES IN THE GEL TUBE DO NOT SEPARATE CLEARLY + PRESENCE OF BUBBLES ON THE SURFACE + DEPOSIT OF GEL WITH PRESENCE OF BLOOD ON THE WALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020836 BD VACUTAINER LH PST II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1053915

    Patients

    Seq Age Sex Outcome Treatment
    1