BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 8496314 · Received April 9, 2019

    Report

    Report Number
    9617032-2019-00415
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 16, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODES FOR GEL SMEARING AND POOR BARRIER SEPARATION WITH THE INCIDENT LOTS WERE OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR TESTING AND UPON COMPLETION, THE ISSUES RELATING TO GEL SMEARING AND POOR BARRIER SEPARATION WERE NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOTS AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODES FOR GEL SMEARING AND POOR BARRIER SEPARATION WITH THE INCIDENT LOTS WERE OBSERVED. ADDITIONALLY, TESTING OF THE RETAIN SAMPLES WAS CONDUCTED AND NO ISSUES WERE OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOAM AND POOR GEL MIGRATION WERE NOTICED IN THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES AFTER CENTRIFUGATION. LOT #'S 8242671 AND 8331522 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WE ARE USERS OF THE BD PRODUCTS REF. (B)(4). FOR SEVERAL WEEKS, WE FACE DIFFERENT ISSUES WHEN SAMPLING DURING THE CENTRIFUGATION (FOAM, POOR GEL MIGRATION). LOTS INVOLVED ARE 8242671 AND 8331522."

    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 #: 8242671, MEDICAL DEVICE EXPIRATION DATE: 2020-03-31, DEVICE MANUFACTURE DATE: 2018-08-30. MEDICAL DEVICE LOT #: 8331522, MEDICAL DEVICE EXPIRATION DATE: 2020-05-31, DEVICE MANUFACTURE DATE: 2018-11-27. (B)(6). DEVICE EVALUATED BY MFR: 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 THAT FOAM AND POOR GEL MIGRATION WERE NOTICED IN THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES AFTER CENTRIFUGATION. LOT #'S 8242671 AND 8331522 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE USERS OF THE BD PRODUCTS REF. 367376. FOR SEVERAL WEEKS, WE FACE DIFFERENT ISSUES WHEN SAMPLING DURING THE CENTRIFUGATION (FOAM, POOR GEL MIGRATION). LOTS INVOLVED ARE 8242671 AND 8331522."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287590 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other