BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 9764333 · Received February 27, 2020

    Report

    Report Number
    1911916-2020-00192
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    February 4, 2020
    Report Date
    February 21, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 40 SAMPLES WERE RECEIVED. THEY CAME IN SEALED PACKAGING BLISTERS. THEY ARE 60 ML AND WERE VISUALLY INSPECTED AND NO DEFECTS WERE OBSERVED. THEY WERE TESTED FOR LEAKAGE AND THEY ALL PASSED. THE BARREL SCALE MARKING AND PACKAGING TOP WEB ARE AS 60 ML. 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 # 9120824 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: UNDETERMINED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD 60ML SYRINGE LUER-LOK¿ TIP LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309653 BATCH NO.: 9120824. 1 OF 3 - OCCURRENCE DATE (B)(6) 2020. IT WAS REPORTED THE PLUNGER SEAL FAILED CAUSING FLUID TO LEAK FROM THE PLUNGER. VERBATIM: PLUNGER SEAL FAILED CAUSING FLUID TO LEAKING FROM PLUNGER. THIS OCCURRED ONCE DURING TRANSPORTATION AND TWICE WHILE DRAWING FLUID INTO THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230622 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 9120824 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other