BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL S/C 48

    MDR report key: 9649153 · Received January 30, 2020

    Report

    Report Number
    1911916-2020-00077
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 13, 2020
    Report Date
    January 15, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED. IT CAME IN THE SEALED PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED USING A 10X MAGNIFIER LENS. ONE SIDE OF THE BARREL FLANGE HAS BURNT PLASTIC; THIS IS ON THE EDGE OF THE BARREL FLANGE. THE BOTTOM WEB HAS EMBEDDED BURNT PLASTIC. IT IS LOCATED TOWARDS THE AREA WHERE THE BOTTOM AREA OF THE SYRINGE IS. BURNS CAN BE CAUSED WHEN THERE IS BLOCKAGE IN THE MOLD VENTS/ GATES WHICH CAN CAUSE BURNS ON THE FLANGE OF THE SYRINGE DURING MOLDING PROCESS. 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. 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. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 9120839 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: BURNS CAN BE CAUSED WHEN THERE IS BLOCKAGE IN THE MOLD VENTS/ GATES WHICH CAN CAUSE BURNS ON THE FLANGE OF THE SYRINGE DURING MOLDING PROCESS. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD¿ SYRINGE 20ML LL S/C 48 HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER. UNFORTUNATELY WE HAVE FOUND A 20ML SYRINGE (LOT# 9120839) WITH FOREIGN MATTER INSIDE. ON THE FLANGE OF THE SYRINGE IS A BROWN-GREEN SUBSTANCE, AND BY THE TIP OF THE SYRINGE IS WHAT LOOKS LIKE EITHER COBWEB OR CLOTHING FLUFF. WE HAVE KEPT THE SYRINGE SEALED IN ITS PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113596 BD SYRINGE 20ML LL S/C 48 PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 9120839 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Other