BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH BD LUER-LOK¿ TIP

    MDR report key: 8233230 · Received January 10, 2019

    Report

    Report Number
    1911916-2018-00832
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 24, 2018
    Report Date
    February 19, 2019
    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
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. IT WAS TESTED FOR VOLUMETRIC ACCURACY. GIVING 10.16; THE SPECIFICATION IS 9.5 GRAMS TO 10.50 GRAMS. IT IS WITHIN SPECIFICATION THEREFORE FAILURE MODE IS NOT VERIFIED. 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. THIS IS THE 1ST COMPLAINT FOR THE LOT# 6252555 FOR THE SAME DEFECTS OR SYMPTOMS. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF LOT # 6252555 DURING THIS PRODUCTION RUN. FAILURE NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD¿ SYRINGE WITH BD LUER-LOK¿ TIP THERE WAS AN ISSUE WITH READING 52 ML WHEN 50 ML OF LIQUID WAS DRAWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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 READING 52 ML WHEN 50 ML OF LIQUID WAS DRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25921 BD¿ SYRINGE WITH BD LUER-LOK¿ TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 6252555 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other