BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 10199712 · Received June 26, 2020

    Report

    Report Number
    1911916-2020-00584
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    June 9, 2020
    Report Date
    June 10, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: AN ADDITIONAL PHONE # WAS PROVIDED AS (B)(6). INITIAL REPORTER FACILITY NAME: (B)(6). (B)(4). INVESTIGATION SUMMARY: NO SAMPLE OR PHOTO WERE PROVIDED BY CUSTOMER FOR EVALUATION. THEREFORE, AN ANALYSIS WAS NOT POSSIBLE TO PERFORM AND THE SYMPTOM REPORTED BY THE CUSTOMER CAN¿T BE CONFIRMED. HOWEVER, A PROBABLE CAUSE CAN BE ATTRIBUTED WHEN DROPLET OF SILICONE COULD BE SEEN SINCE IT IS ADDED TO THE INNER WALL OF THE SYRINGE BARREL TO MAKE THE PLUNGER ROD RUBBER STOPPER MOVEMENT SMOOTHER. THE SILICONE IS MEDICAL GRADE. THE PROCESS INSPECTIONS PERFORMED WHILE PRODUCING THIS LOT AND WERE ACCEPTED. NO ISSUES WERE REPORTED. 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. 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. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 52475 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH #. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 30ML LL S/C 56 EXPERIENCED LIQUID/MOISTURE/DROPLETS IN SYRINGE WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 302832, BATCH NO: 0052475. EVENT DESCRIPTION: WE JUST OPENED A BOX (CASE) OF BD 30ML SYRINGES. IN ALL OF THE SYRINGES THERE APPEARS TO BE CONDENSATION INSIDE THEM. THESE ARE SINGLE WRAPPED SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667973 SYRINGE 30ML LL S/C 56 PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302832 0052475 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other