BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE PAK

    MDR report key: 9837092 · Received March 16, 2020

    Report

    Report Number
    9610847-2020-00101
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    March 5, 2020
    Report Date
    March 9, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THREE PHOTOS WERE PROVIDED. THEY SHOW A PLUNGER ROD WITH THE RUBBER STOPPER. THE SILICONE APPLIED TO THE STOPPER IS VISIBLE WITH NO RUN OUTS OR ANY NOTICEABLE EXCESS. ONE PHOTO SHOWS A BARREL WITH NO PLUNGER ROD-RUBBER STOPPER. IT SHOWS WHAT APPEAR AN AIR BUBBLE IN THE BARREL WALL OR A DROP OF A SUBSTANCE. FROM THE PHOTO THERE IS NO WAY TO CONFIRM WHAT EXACTLY IS. ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. THIS IS THE 1ST COMPLAINT FOR LOT # 9242252 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THESE BATCH #S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER (SILICONE) PAST PLUNGER WITH A BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE PAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS). IT WAS REPORTED THAT MULTIPLE SYRINGES WERE OBSERVED TO HAVE WHAT WAS THOUGHT TO BE SILICONE FLUID PAST THE PLUNGER SEAL BUT AFTER REMOVING THE PLUNGER, THE FLUID SOLIDIFIED INTO A CRUST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301664 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9242252

    Patients

    Seq Age Sex Outcome Treatment
    1 Other