BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 7823303 · Received August 28, 2018

    Report

    Report Number
    1911916-2018-00479
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    July 30, 2018
    Report Date
    October 4, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWELVE SAMPLES WERE RECEIVED FOR EVALUATION. THE SAMPLES HAD FOREIGN MATTER ON THE STOPPERS THEREFORE FAILURE MODE IS VERIFIED. THE FOREIGN MATTER WAS IDENTIFIED AS PLASTIC DUST. PLASTIC DUST MAY BE CREATED THROUGHOUT THE MANUFACTURING PROCESS VIA CONVEYING AND VIBRATION OF PLASTIC COMPONENTS. 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 FIRST COMPLAINT FOR THE LOT# 8082820 FOR THE SAME DEFECT OR SYMPTOM. NO RELATED DEFECTS OR QNS RECORDED IN THE DHR. MACHINERY IS CLEANED MULTIPLE TIMES EACH DAY. ALL OPERATORS FOLLOW A GOWNING PROCEDURE TO REDUCE FOREIGN MATTER BROUGHT INTO THE MANUFACTURING AREA. ALL SYRINGES HAVE THE INTERIOR FLUSHED WITH IONIZED AIR TO REMOVE ANY POTENTIAL FOREIGN MATERIALS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ TIP SYRINGE CONTAINED FOREIGN MATTER DESCRIBED AS "TINY PIECE OF PLASTIC". NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ TIP SYRINGE CONTAINED FOREIGN MATTER DESCRIBED AS "TINY PIECE OF PLASTIC". NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666447 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8082820 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other