BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML E/T

    MDR report key: 12363453 · Received August 24, 2021

    Report

    Report Number
    3003152976-2021-00501
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    July 27, 2021
    Report Date
    October 12, 2021
    Product Code
    FMF
    UDI-DI
    30382903008668
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: PHOTOS RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE PICTURES, IT CAN BE OBSERVED THE PLUNGER IS BROKEN FROM LOT 2007082. UPON VISUAL INSPECTION OF THE PICTURE OF THE SYRINGE FROM LOT 2101084 NO LEAKAGE PAST THE STOPPER CAN BE SEEN AND NO MOLDING DEFECT OR HIT IS DETECTED THAT CAN LEAD TO THE DEFECT NOTICED BY CUSTOMER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2007082, 2101084 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. POSSIBLE ROOT CAUSE FOR DAMAGED PLUNGER CAN BE A RESULT OF A HIT DURING MANUFACTURING PROCESS. AREAS WHERE PIECES ARE TRANSPORTED IN MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE FOR LEAKAGE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION AND THERE IS NO DAMAGE ON THE PRODUCT. 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 H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 60ML E/T PLUNGER ROD BROKE AFTER DRAWING UP MEDICATION. ADDITIONALLY, ANOTHER SYRINGE LEAKED PAST THE STOPPER WHEN DRAWING UP MEDICINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE WALL BREAKS AFTER DRUG WITHDRAWAL. LEAKAGE FROM THE SYRINGE AFTER THE MEDICINE IS DRAWN."

    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 #: 2007082, MEDICAL DEVICE EXPIRATION DATE: 2025-06-30, DEVICE MANUFACTURE DATE: 2020-07-27. MEDICAL DEVICE LOT #: 2101084, MEDICAL DEVICE EXPIRATION DATE: 2025-12-31, DEVICE MANUFACTURE DATE: 2021-01-22. 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 SYRINGE 60ML E/T PLUNGER ROD BROKE AFTER DRAWING UP MEDICATION. ADDITIONALLY, ANOTHER SYRINGE LEAKED PAST THE STOPPER WHEN DRAWING UP MEDICINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE WALL BREAKS AFTER DRUG WITHDRAWAL. LEAKAGE FROM THE SYRINGE AFTER THE MEDICINE IS DRAWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258945 SYRINGE 60ML E/T PISTON SYRINGE FMF 300866 SEE SECTION H.10. 30382903008668

    Patients

    Seq Age Sex Outcome Treatment
    1