BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 16212649 · Received January 19, 2023

    Report

    Report Number
    1911916-2023-00006
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    January 2, 2023
    Report Date
    January 24, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028306
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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

    H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WAS FOREIGN MATTER IN THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THERE IS FOREIGN MATTER ADHERED TO THE INNER WALL OF THE SYRINGE BARREL AT THE BOTTOM OF THE SYRINGE. THE FOREIGN MATTER IS ABOUT 3/8" LONG AND 3/32" WIDE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE FOREIGN MATTER WAS SENT TO A LABORATORY FOR ADDITIONAL ANALYSIS. A FLUSH TEST WAS PERFORMED AND AFTER TEN ATTEMPTS IT WAS NOT POSSIBLE TO FLUSH OUT THE FOREIGN MATTER; IT STAYED ADHERED TO THE INNER WALL OF THE SYRINGE BARREL. THE LABORATORY REPORT ALSO CONFIRMED DURING FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS THAT THE FOREIGN MATTER IS SILICONE BASED. THE SILICONE LUBRICANT IS MEDICAL GRADE, A PART OF THE MANUFACTURING PROCESS, AND IS ADDED TO THE RUBBER STOPPER AND INNER WALL OF THE SYRINGE TO THE MAKE THE PLUNGER ROD-RUBBER STOPPER MOVEMENT SMOOTHER. THIS DEFECT COULD OCCUR IF THE SILICONE WAS NOT EVENLY DISTRIBUTED WHEN THE SYRINGE WAS BEING LUBRICATED. THE PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 2040607. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD LUER-LOK¿ TIP SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOREIGN SUBSTANCES IN THE SYRINGE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD LUER-LOK¿ TIP SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOREIGN SUBSTANCES IN THE SYRINGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113707 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2040607 00382903028306

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown