BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 14961909 · Received July 8, 2022

    Report

    Report Number
    1911916-2022-00342
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    May 6, 2022
    Report Date
    July 6, 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
    IN
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS PARTICULATE VISUALIZED IN A TUBING LINE. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO IS AT 48X MAGNIFICATION AND THE OTHER IS AT 75X MAGNIFICATION. THE PHOTOS SHOW A YELLOWISH PARTICULATE. THE IR SPECTRA IS CONSISTENT WITH WOOD OR WOOD BASED PRODUCTS LIKE CARDBOARD OR CHIPBOARD. IN THE SYRINGE ASSEMBLY PROCESS, THERE ARE NO MATERIALS LIKE WOOD OR CARDBOARD A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 0274637. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THE 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 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. DEVICE EVALUATED BY MFR: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A PARTICULATE IN THE TUBING LINE DURING USE OF BD LUER-LOK¿ TIP SYRINGE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PERSONNEL PERFORMING THE CATION EXCHANGE (CEX) CHROMATOGRAPHY PROCESS OBSERVED A PARTICULATE IN THE TUBING LINE THROUGH WHICH PRODUCT WAS BEING PUMPED (OUT OF THE PRODUCT BAG AND INTO AN INTERMEDIATE BOTTLE). THE PARTICULATE WAS OBSERVED IN THE PRODUCT FLUID WHICH HAD JUST BEGUN PUMPING THROUGH THE TUBING LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085494 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0274637 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown