BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50ML LL BRAZIL

    MDR report key: 13777532 · Received March 16, 2022

    Report

    Report Number
    1911916-2022-00140
    Event Type
    Malfunction
    Date Received
    March 16, 2022
    Date of Event
    February 28, 2022
    Report Date
    June 17, 2024
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS A DARK FOREIGN MATTER OBSERVED IN THE LUER. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE IN A PACKAGING BLISTER. THE SYRINGE HAS A BLACK SPECK AT THE LUER TIP THAT APPEARS TO BE EMBEDDED DEGRADED RESIN. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303552, LOT NUMBER 1103473. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS 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 BD SYRINGE 50ML LL BRAZIL CONTAINED FOREIGN MATERIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OBSERVED A DARK FOREIGN MATTER IN LUER (WHERE THE NEEDLE IS ATTACHED), AS IT WAS BURNT."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245547 BD SYRINGE 50ML LL BRAZIL PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1103473

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown