BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 50ML SYRINGE LUER-LOK¿ TIP

    MDR report key: 14595591 · Received June 3, 2022

    Report

    Report Number
    1911916-2022-00286
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 6, 2022
    Report Date
    May 18, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER FACILITY NAME: (B)(4) MEDICINE (AKA UNIVERSITY (B)(4) HEALTH SYSTEM) INVESTIGATION SUMMARY: THE CUSTOMER RETURNED SAMPLES WITHOUT REPORTING ANY DEFECTS. TO AID IN THE INVESTIGATION, FOUR SAMPLES AND SEVEN PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THREE SAMPLES CAME IN SEALED PACKAGING BLISTERS FROM LOT 2033191 AND ONE SAMPLE CAME IN AN OPENED PACKAGING BLISTER FROM LOT 1363553. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SEVEN PHOTOS PROVIDED SHOW SOME OF THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 1363553. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES THAT COULD HAVE CONTRIBUTED TO TO ANY DEFECTS DURING THE PRODUCTION OF THESE LOTS. TO DATE, THERE HAVE BEEN NO ISSUES REPORTED FOR ANY OF THE LOTS PROVIDED. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD 50ML SYRINGE LUER-LOK¿ TIP EXPERIENCED DROPLETS WITHIN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER NOTED PRESENT ON DEVICE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979461 BD 50ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1363553 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown