BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VET SSTII 40TUBE PLH 13X75 3.5 PLBL GLD

    MDR report key: 8275798 · Received January 24, 2019

    Report

    Report Number
    9617032-2019-00004
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    January 3, 2019
    Report Date
    March 6, 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 MODE FOR HAEMOLYSED SAMPLES POOR GEL MIGRATION WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES RELATING TO SAMPLE QUALITY WAS OBSERVED AS ALL RESULTS DEMONSTRATED SATISFACTORY PERFORMANCE. 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 PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR HEMOLYSIS WITH THE INCIDENT LOTS WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE RETAIN SAMPLES WAS CONDUCTED AND NO ISSUES WERE FOUND. 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 THERE WAS HEMOLYSIS ON A VET SSTII 40TUBE PLH 13X75 3.5 PLBL GLD DURING VETERINARY SAMPLING.

    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 #: 8263905. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2018-09-20. MEDICAL DEVICE LOT #: 8274625. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2018-09-20. MEDICAL DEVICE LOT #: 8128711. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2018-09-20. 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 THERE WAS HEMOLYSIS ON A VET SSTII 40TUBE PLH 13X75 3.5 PLBL GLD DURING VETERINARY SAMPLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68299 VET SSTII 40TUBE PLH 13X75 3.5 PLBL GLD BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other