BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60 ML BD¿ SYRINGE WITH BD LUER-LOK¿ TIP

    MDR report key: 6853356 · Received September 8, 2017

    Report

    Report Number
    1911916-2017-00215
    Event Type
    Malfunction
    Date Received
    September 8, 2017
    Date of Event
    August 16, 2017
    Report Date
    November 20, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SAMPLE WAS RECEIVED IN THE PLANT FOR EVALUATION. BREAKOUT SUSTAIN WAS PERFORMED ON PART FROM BD MEDICAL AND WAS IN SPEC. THIS IS AN UNCONFIRMED DEFECT. DHR: PRODUCT WAS RAN ON 860 #2 LINE ON 5/6/2017. AT BLISTERPAK THERE WERE 18 INSPECTIONS ON 144 PARTS WITH ZERO DEFECTS FOUND. AT PRINT/ASSY THERE WERE 18 INSPECTIONS ON 900 PARTS WITH ZERO DEFECTS FOUND. INVESTIGATION CONCLUSION: BREAKOUT SUSTAIN WAS PERFORMED ON BD MEDICAL SYRINGE SPEC: BREAKOUT-0.0-9.0LBS SUSTAIN-0.0-5.0LBS. READING WAS BREAKOUT-1.78LBS AND SUSTAIN-.96LBS. COMPLAINT TRENDING REVIEW OF THIS LOT AND OR PRODUCT FAMILY FOR THIS ISSUE REVEALS ONE COMPLAINT. SILICONE WEIGHT TESTING IS PERFORMED TWICE DURING THE BATCH (MID AND END). SPEC: .0055-.0120GRAMS. READINGS WERE MIN. FOR SILICONE.0075G AND MAX WAS .0096G. ROOT CAUSE DESCRIPTION: BREAKOUT SUSTAIN WAS PERFORMED ON PART FROM BD MEDICAL AND WAS IN SPEC. THIS IS A UNCONFIRMED DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER MOVEMENT WAS DIFFICULT ON A 60 ML BD¿ SYRINGE WITH BD LUER-LOK¿ TIP DURING USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633259 60 ML BD¿ SYRINGE WITH BD LUER-LOK¿ TIP SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 7086739

    Patients

    Seq Age Sex Outcome Treatment
    1 Other