BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 8782341 · Received July 11, 2019

    Report

    Report Number
    3003152976-2019-00458
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    July 2, 2019
    Report Date
    September 19, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT: 1904221, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. TEN RETAINED SAMPLES OF THE SAME LOT WERE USED FOR EVALUATION, NO DAMAGE OR MOLDING DEFECT WAS OBSERVED THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THROUGHOUT THE MANUFACTURING PROCESS, FORCE TESTING AND SILICONE CONTENT TESTS ARE CONDUCTED FOR EACH LOT. ALL RETAINED SAMPLES WERE EVALUATED AND FOUND TO BE WITHIN REQUIRED SPECIFICATIONS. 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: 1904221 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. TEN RETAINED SAMPLES OF 50LL LOT: 1904221 ARE EVALUATED. UPON VISUAL INSPECTION OF THESE SAMPLES NO DAMAGE OR MOLDING DEFECT CAN BE OBSERVED IN THEM THAT COULD BE RELATED TO THE ALLEGED DEFECT. SILICONE CONTENT, BREAK OUT AND SUSTAINING FORCE TESTS ARE DONE TO EVERY LOT DURING MANUFACTURING PROCESS. MINIMUM REFERENCE VALUE FOR SILICONE CONTENT IN 50ML LL SYRINGES IS 6MG AND MAXIMUM LIMIT IS 25MG. MAXIMUM LIMIT FOR BREAK OUT AND SUSTAINING FORCE TEST ARE 9 LB AND 5 LB RESPECTIVELY ACCORDING TO PROCEDURE JG-500. RESULTS FOR THESE TESTS DURING MANUFACTURING PROCESS OF LOT: 1904221 ARE CHECKED FINDING THEM WITHIN THE PROCEDURE LIMITS PREVIOUSLY MENTIONED. SILICONE CONTENT, BREAK OUT AND SUSTAINING FORCE TESTS ARE PERFORMED WITH THE RETAINED SAMPLES FINDING ALL RESULTS WITHIN SPECIFICATION LIMITS PREVIOUSLY MENTIONED. SINCE NO DEFECT HAS BEEN FOUND IN VISUAL INSPECTION OF RETAINED SAMPLES AND TEST RESULTS DURING MANUFACTURING PROCESS OF THIS LOT AND WITH RETAINED ARE WITHIN SPECIFICATION LIMITS, THE ROOT CAUSE OF THIS INCIDENT 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. H3 OTHER TEXT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 50ML LL EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR ANAESTHETIC TEAM HAS HAD A PROBLEM WITH THE 50ML PLASTIPAK SYRINGES AS THEY HAVE GOT STUCK HALFWAY ALONG THE INFUSION AND THIS CAUSED A CLINICAL INCIDENCE AS THE PUMP ALARM WAS GOING OFF LATE. THEY SEEM TO THINK THERE IS A RESISTANCE IN THE BARREL OF THE SYRINGE, AND OTHERS IN THE BATCH. THE BATCH, 1904221, HAS BEEN TAKEN OUT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (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 AN UNSPECIFIED NUMBER OF SYRINGE 50ML LL EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR ANAESTHETIC TEAM HAS HAD A PROBLEM WITH THE 50ML PLASTIPAK SYRINGES AS THEY HAVE GOT STUCK HALFWAY ALONG THE INFUSION AND THIS CAUSED A CLINICAL INCIDENCE AS THE PUMP ALARM WAS GOING OFF LATE. THEY SEEM TO THINK THERE IS A RESISTANCE IN THE BARREL OF THE SYRINGE, AND OTHERS IN THE BATCH. THE BATCH, 1904221, HAS BEEN TAKEN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576598 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 1904221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other