BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER-LOK SYRINGE

    MDR report key: 7635128 · Received June 25, 2018

    Report

    Report Number
    1911916-2018-00326
    Event Type
    Malfunction
    Date Received
    June 25, 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. UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ LUER-LOK SYRINGE HAD; FM-PARTICULATE/CONTAMINATION, DAMAGE, INCLUSIONS, PRINT ISSUE. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: 7170605, MEDICAL DEVICE EXPIRATION DATE: 06/30/2022, DEVICE MANUFACTURE DATE: 06/19/2017. MEDICAL DEVICE LOT #: 7170606, MEDICAL DEVICE EXPIRATION DATE: 06/30/2022 , DEVICE MANUFACTURE DATE: 06/19/2017. MEDICAL DEVICE LOT #: 7170625, MEDICAL DEVICE EXPIRATION DATE: 06/30/2022, DEVICE MANUFACTURE DATE: 06/19/2017. MEDICAL DEVICE LOT #: 7227658, MEDICAL DEVICE EXPIRATION DATE: 08/31/2022 , DEVICE MANUFACTURE DATE: 08/15/2017. (B)(6). 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 THE BD¿ LUER-LOK SYRINGE HAD; FM-PARTICULATE/CONTAMINATION, DAMAGE, INCLUSIONS, PRINT ISSUE. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475898 BD¿ LUER-LOK SYRINGE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other