BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 50 ML

    MDR report key: 13841041 · Received March 21, 2022

    Report

    Report Number
    1911916-2022-00146
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    March 4, 2022
    Report Date
    June 17, 2024
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THERE WAS FOREIGN MATTER. TO AID IN THE INVESTIGATION, THREE USED SAMPLES WITH NO PACKAGING BLISTERS AND RESIDUES OF A DRUG, AND THREE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS. THE REPORTED PARTICLES WERE LOCATED IN THE SYRINGE. EACH OF THE PARTICLES ARE FLEXIBLE AND AFTER TOUCHING THEM WITH A METAL NEEDLE SEPARATED INTO SMALLER PIECES. THEY ARE NOT PLASTICS PARTICLES AS THE PLASTIC PARTICLES ARE HARD. THEY APPEARED TO BE FROM THE SILICONE APPLIED TO THE RUBBER STOPPERS. THE THREE PHOTOS SHOW THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 9240114. 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 RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT 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 PRIOR TO USING THE BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 50 ML, FOREIGN MATTER WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES HAVE A THREAD LIKE PARTICULATE ON THE SURFACE OF THE RUBBER STOPPER AND BETWEEN THE RIBS OF THE RUBBER STOPPER AND WALL OF THE SYRINGE BARREL.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890595 BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 50 ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 9240114 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown