BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 7594520 · Received June 12, 2018

    Report

    Report Number
    1911916-2018-00328
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    June 1, 2018
    Report Date
    August 8, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE PROVIDED FOR EVALUATION THEREFORE FAILURE MODE COULD NOT BE VERIFIED AND ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. NO RELATED DEFECTS OR QNS WERE RECORDED IN THE DHR. UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK¿ SYRINGE THERE WAS AN ISSUE WITH MULTIPLE ISSUES. IT WAS STATED ¿THERE WAS FOREIGN MATTER, DEVICE DAMAGE, INCLUSIONS AND SCALE PRINT MARKING ISSUES.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    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 #: 7080847; MEDICAL DEVICE EXPIRATION DATE: 2022-03-31; DEVICE MANUFACTURE DATE: 2017-03-21. MEDICAL DEVICE LOT #: 7143793; MEDICAL DEVICE EXPIRATION DATE: 2022-05-31; DEVICE MANUFACTURE DATE: 2017-05-23. MEDICAL DEVICE LOT #: 7143808; MEDICAL DEVICE EXPIRATION DATE: 2022-05-31; DEVICE MANUFACTURE DATE: 2017-05-23. 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 WITH THE USE OF THE BD LUER-LOK¿ SYRINGE THERE WAS AN ISSUE WITH MULTIPLE ISSUES. IT WAS STATED ¿THERE WAS FOREIGN MATTER, DEVICE DAMAGE, INCLUSIONS AND SCALE PRINT MARKING ISSUES.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436155 BD LUER-LOK¿ SYRINGE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other