BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH BD LUER-LOK¿ TIP

    MDR report key: 7495347 · Received May 8, 2018

    Report

    Report Number
    1911916-2018-00205
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 24, 2018
    Report Date
    July 18, 2018
    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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES WERE RECEIVED FOR EVALUATION THEREFORE FAILURE MODE COULD NOT BE VERIFIED AND ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, FOR 60ML LEAKAGE ISSUES A CAPA (CORRECTIVE ACTION PREVENTIVE ACTION) HAS BEEN OPENED TO EVALUATE THIS ISSUE. THIS IS THE FIRST COMPLAINT FOR THE LOT # 7180641 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 7180641 DURING THIS PRODUCTION RUN. INVESTIGATION CONCLUSION: ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD¿ SYRINGE WITH BD LUER-LOK¿ TIP THERE WAS AN ISSUE WITH LEAKAGE. IT WAS STATED ¿THERE WAS A LEAK OF MEDICATION THROUGH THE PLUNGER STOPPER.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD¿ SYRINGE WITH BD LUER-LOK¿ TIP THERE WAS AN ISSUE WITH LEAKAGE. IT WAS STATED ¿THERE WAS A LEAK OF MEDICATION THROUGH THE PLUNGER STOPPER.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336022 BD¿ SYRINGE WITH BD LUER-LOK¿ TIP SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 7180641 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other