BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL BNS

    MDR report key: 10348073 · Received July 30, 2020

    Report

    Report Number
    1911916-2020-00702
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 7, 2020
    Report Date
    August 10, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THIS LOT WAS PRODUCED FOR 0.179MM UNITS WITH 1 COMPLAINT IT HAS A CPM OF 5.5. WE WILL CONTINUE MONITORING AND TRENDING THIS PRODUCT AND LOT# FOR THIS SYMPTOM. 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 H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY FOUR PHOTOS WERE PROVIDED FOR EVALUATION. THEY SHOW A SYRINGE BARREL WITH BLACK SPECKS- FROM THE PHOTO. IT LOOKS LIKE DEGRADED RESIN FROM MOLDING OR BLACK INK FROM THE BARREL PRINTING PROCESS. BASED ON THE IMAGES PROVIDED. IT COULD BE DEGRADED RESIN FROM THE MOLDING PROCESS OR BLACK SPECKS FROM THE BARREL PRINTING PROCESS. THE REPORTED CONDITION IS CONFIRMED. THIS LOT WAS PRODUCED FOR 0.179MM UNITS WITH ONE COMPLAINT. IT HAS A CPM OF 5.5. WE WILL CONTINUE MONITORING AND TRENDING THIS PRODUCT AND LOT# FOR THIS SYMPTOM. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR THE ASSOCIATED ASSEMBLY BATCHES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 26 SYRINGE 30ML LL BNS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301033, BATCH NO: 0003695. EVENT DESCRIPTION: DURING ASSEMBLY PROCESS 26 EACH DISCOVERED WITH LOOSE DEBRIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 26 SYRINGE 30ML LL BNS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301033 BATCH NO: 0003695. EVENT DESCRIPTION: DURING ASSEMBLY PROCESS 26 EACH DISCOVERED WITH LOOSE DEBRIS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 26 SYRINGE 30ML LL BNS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301033 BATCH NO: 0003695. EVENT DESCRIPTION: DURING ASSEMBLY PROCESS 26 EACH DISCOVERED WITH LOOSE DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812624 SYRINGE 30ML LL BNS PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0003695

    Patients

    Seq Age Sex Outcome Treatment
    1 Other