BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL BNS

    MDR report key: 9404911 · Received December 3, 2019

    Report

    Report Number
    1213809-2019-01208
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 15, 2019
    Report Date
    January 15, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9142635. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-05-22. MEDICAL DEVICE LOT #: 9134950. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-05-14.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO AND EIGHT LOOSE 10ML SYRINGES WERE RECEIVED AND EVALUATED. IT APPEARED THE "CONDENSATION" WAS SILICONE AND WAS THE NORMAL AND EXPECTED AMOUNT OF SILICONE PER PRODUCT SPECIFICATION. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML LL BNS EXPERIENCED LIQUID/MOISTURE/DROPLETS IN SYRINGE WHICH WAS NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301029 BATCH NO: UNKNOWN CUSTOMER REPORTS THE BD SYRINGE LOOKS LIKE THERE IS CONDENSATION IN THE SYRINGE. REPORTS THIS HAS HAPPENED ONCE BEFORE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML LL BNS EXPERIENCED LIQUID/MOISTURE/DROPLETS IN SYRINGE WHICH WAS NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301029; BATCH NO: UNKNOWN. CUSTOMER REPORTS THE BD SYRINGE LOOKS LIKE THERE IS CONDENSATION IN THE SYRINGE. REPORTS THIS HAS HAPPENED ONCE BEFORE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN: (B)(6) USA HAS BEEN USED AS A DEFAULT.  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 AN UNSPECIFIED NUMBER OF SYRINGE 10ML LL BNS EXPERIENCED LIQUID/MOISTURE/DROPLETS IN SYRINGE WHICH WAS NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301029 BATCH NO: UNKNOWN. CUSTOMER REPORTS THE BD SYRINGE LOOKS LIKE THERE IS CONDENSATION IN THE SYRINGE. REPORTS THIS HAS HAPPENED ONCE BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202079 SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other