BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 11508072 · Received March 17, 2021

    Report

    Report Number
    1911916-2021-00213
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 19, 2021
    Report Date
    March 11, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653 AND LOT NUMBER 0140934. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE PHYSICAL SAMPLE AND ONE PHOTO WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE CAME IN AN OPENED PACKAGING BLISTER WITH A HAND DRAWN CIRCLE ON THE SYRINGE BARREL IN THE AREA WHERE THE RUBBER STOPPER IS. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS AND THERE IS A PARTICLE ABOUT 1/64" THAT WAS OBSERVED. THE PLUNGER ROD-RUBBER STOPPER WAS REMOVED AND THE PARTICLE IS MEDICAL GRADE SILICONE. DURING MANUFACTURING, MEDICAL GRADE SILICONE IS APPLIED TO THE RUBBER STOPPER AND THE INNER WALL OF THE SYRINGE BARREL. IT MAY HAVE BEEN THAT A SMALL DROP OF THIS MEDICAL GRADE SILICONE WAS OBSERVED BY THE CUSTOMER. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED DURING THE INVESTIGATION. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. 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 · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404677 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 0140934 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1