BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS SP120

    MDR report key: 8945971 · Received August 29, 2019

    Report

    Report Number
    3003152976-2019-00596
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 13, 2019
    Report Date
    September 20, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1903015 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1903015 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO FOREIGN MATTER WAS OBSERVED ON THE SYRINGES OR WITHIN THE BLISTER PACKAGING. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. NO SAMPLE OR PICTURE HAS BEEN RECEIVED FOR INVESTIGATION. DHR OF LOT 1903015 IS REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. TEN RETAINED SAMPLES OF 1ML LS LOT 1903015 ARE EVALUATED. UPON VISUAL INSPECTION OF THESE 10 SAMPLES, NO FOREIGN MATTER CAN BE OBSERVED INSIDE THE SYRINGES NEITHER INSIDE THE BLISTERS. ACCORDING TO INSPECTION PLAN PROCEDURE JG-500, 200 UNITS ARE INSPECTED EVERY 2 PALLETS BY QUALITY CONTROL TEAM. SINCE NO ISSUES WERE IDENTIFIED AND MANUFACTURING RECORD STABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, AND NO FOREIGN MATTER IS OBSERVED IN RETAINED SAMPLES EVALUATED, THE ROOT CAUSE OF THE ALLEGED DEFECT CANNOT 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 QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. SINCE NO ISSUES WERE IDENTIFIED AND MANUFACTURING RECORD STABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, AND NO FOREIGN MATTER IS OBSERVED IN RETAINED SAMPLES EVALUATED, THE ROOT CAUSE OF THE ALLEGED DEFECT CANNOT BE DETERMINED. BASED ON QDA LIMITS FOR THIS PRODUCT AND DEFECT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 1ML LS SP120 EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS A LOT OF VISIBLE OBSERVABLE DARK DIRT INSIDE THE STERILE SYRINGE AND DUE TO THIS DRUG WORTH (B)(6) GOT WASTED.

    Additional Manufacturer Narrative · 1

    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 1ML LS SP120 EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS A LOT OF VISIBLE OBSERVABLE DARK DIRT INSIDE THE STERILE SYRINGE AND DUE TO THIS DRUG WORTH 800¿ GOT WASTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741812 SYRINGE 1ML LS SP120 SYRINGE FMF BECTON DICKINSON, S.A. 1903015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other