BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 8458042 · Received March 27, 2019

    Report

    Report Number
    9617032-2019-00355
    Event Type
    Malfunction
    Date Received
    March 27, 2019
    Date of Event
    March 13, 2019
    Report Date
    May 3, 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
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR EVALUATION. THE SAMPLES, ALONG WITH RETENTION SAMPLES SELECTED FROM BD INVENTORY, WERE TESTED AND UPON COMPLETION, THE ISSUE RELATING TO OIL GEL GLOBULES WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT 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 AND RETAIN SAMPLES, THE CUSTOMERS INDICATED FAILURE MODE FOR OIL GEL GLOBULES WITH THE INCIDENT LOT WAS 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 A BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES HAD SEPARATION ISSUES. THE FOLLOWING WAS REPORTED, "THEY HAVE BEEN TAKING ABOUT 4-8 TUBES A DAY IN WHICH THE SEPARATION OF THE GEL AFTER THE CENTRIFUGATION LEAVES AS RESIDUES SMALL SPHERES OF GEL, WHICH CLOG THE MACHINE WHEN ASPIRATING THE SAMPLE AND THUS HAVE DEFECTIVE READINGS.4 LOTS AFFECTED SO FAR: 8093523, 7237720, 7276620 AND 8242658."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8093523. MEDICAL DEVICE EXPIRATION DATE: 2019-09-30. DEVICE MANUFACTURE DATE: 2018-04-03. MEDICAL DEVICE LOT #: 7276620. MEDICAL DEVICE EXPIRATION DATE: 2019-03-31. DEVICE MANUFACTURE DATE: 2017-10-03. MEDICAL DEVICE LOT #: 8242658. MEDICAL DEVICE EXPIRATION DATE: 2020-02-29. DEVICE MANUFACTURE DATE: 2018-08-30. MEDICAL DEVICE LOT #: 7327720. MEDICAL DEVICE EXPIRATION DATE: 2019-05-31. DEVICE MANUFACTURE DATE: 2017-11-23. 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 A BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES HAD SEPARATION ISSUES. THE FOLLOWING WAS REPORTED, " THEY HAVE BEEN TAKING ABOUT 4-8 TUBES A DAY IN WHICH THE SEPARATION OF THE GEL AFTER THE CENTRIFUGATION LEAVES AS RESIDUES SMALL SPHERES OF GEL, WHICH CLOG THE MACHINE WHEN ASPIRATING THE SAMPLE AND THUS HAVE DEFECTIVE READINGS.4 LOTS AFFECTED SO FAR: 8093523, 7237720, 7276620 AND 8242658."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248026 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other