BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COMPLETE CUP KIT

    MDR report key: 8712170 · Received June 19, 2019

    Report

    Report Number
    1917413-2019-01603
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 29, 2019
    Report Date
    June 20, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JSM
    PMA / PMN Number
    K024240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO UNDERFILLING AS ALL SAMPLES MET SPECIFICATIONS. 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 RETAIN SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR UNDERFILLING WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE RETAIN PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. 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

    MATERIAL NO: 364957. BATCH NO: 8213877, 8152702, 8025660. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® URINE COMPLETE CUP KIT THE TUBES IN THE KIT ARE NOT FILLING PROPERLY. THIS OCCURRED ON 5 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.¿ URINE TUBES INCLUDED WITH KIT ARE NOT FILLING PROPERLY.

    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 #: 8213877, MEDICAL DEVICE EXPIRATION DATE: 2020-02-29, DEVICE MANUFACTURE DATE: 2018-08-01. MEDICAL DEVICE LOT #: 8152702, MEDICAL DEVICE EXPIRATION DATE: 2019-12-31, DEVICE MANUFACTURE DATE: 2018-06-01. MEDICAL DEVICE LOT #: 8025660, MEDICAL DEVICE EXPIRATION DATE: 2019-08-31, DEVICE MANUFACTURE DATE: 2018-01-25. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO: 364957, BATCH NO: 8213877, 8152702, 8025660. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® URINE COMPLETE CUP KIT THE TUBES IN THE KIT ARE NOT FILLING PROPERLY. THIS OCCURRED ON 5 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.¿ URINE TUBES INCLUDED WITH KIT ARE NOT FILLING PROPERLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504615 BD VACUTAINER® URINE COMPLETE CUP KIT TRANSPORT CULTURE MEDIUM JSM BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other