BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 15951055 · Received December 9, 2022

    Report

    Report Number
    1911916-2022-00717
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    October 8, 2022
    Report Date
    November 25, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    50382903096539
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED ON THREE SEPARATE OCCASIONS THERE WAS PARTICULATE WHILE SAMPLING. TO AID IN THE INVESTIGATION, THREE FTIR REPORTS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE FTIR REPORTS REFER TO TESTING 15ML CONICAL TUBES CONTAINING HIC POOL MATERIAL. ONE REPORT MENTIONS ONE SAMPLE, ANOTHER REPORT MENTIONS TWO SAMPLES AND THE THIRD REPORT THREE SAMPLES. THE REPORTS INCLUDE PHOTOS TAKEN AT TWO HUNDRED AND FOUR HUNDRED MAGNIFICATIONS. AS WELL AS COMPARISON CHARTS OF THE FOREIGN MATTER VERSUS THE FTIR LIBRARY. THE CONCLUSION IS THE FOREIGN MATTER IS SILICONE, THOUGH THE REPORT DOES NOT MENTION THE PERCENT MATCH TO THE REFERENCE FROM THE LIBRARY. NO OTHER INFORMATION COULD BE OBTAINED FROM THE REPORTS PROVIDED AND NO INFORMATION WAS PROVIDED ON WHERE THE FOREIGN MATTER WAS IN THE BD SYRINGE. THE SYRINGES ARE MANUFACTURED WITH MEDICAL GRADE SILICONE THAT IS APPLIED TO THE INNER WALL SYRINGE BARREL AND RUBBER STOPPER. THIS ALLOWS FOR SMOOTHER MOVEMENT OF THE RUBBER STOPPER IN THE SYRINGE BARREL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 2090548. 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 FTIR REPORTS PROVIDED BY THE CUSTOMER THE DEFECT REPORTED COULD NOT BE CONFIRMED. 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 FOREIGN MATTER WAS FOUND IN THE BD LUER-LOK¿ TIP SYRINGE DURING A SAMPLING EVENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS WAS FOUND DURING ROUTINE SAMPLING OF A PROCESS POOL. LOOSE PARTICULATE FOUND WITHIN SINGLE USE SAMPLING VESSEL." "ON (B)(6) 2022 IN PA1 DURING A SAMPLING EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2907890 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2090548 50382903096539

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown