BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 10114095 · Received June 3, 2020

    Report

    Report Number
    1911916-2020-00517
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    May 26, 2020
    Report Date
    May 28, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    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. (B)(4). INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. IT CAME IN A (B)(6) PLASTIC BAG IN AN OPENED PACKAGING BLISTER. VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS. IT HAS TWO SPECKS OF EMBEDDED DEGRADED RESIN IN THE SYRINGE LUER. ONE PHOTO WAS PROVIDED. IT SHOWS THE SAMPLE RECEIVED WITH THE EMBEDDED DEGRADED RESIN IN THE SYRINGE LUER. EMBEDDED BURNT PLASTIC CAN OCCUR AT THE STARTUP OF AN INJECTION MOLD/PRESS OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE BARREL AND HOT-RUNNER SYSTEM OF THE TOOLING MOLD AND PRESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. 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. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE WITH THE SAMPLE AND PHOTO PROVIDED. THIS IS THE 1ST COMPLAINT FOR LOT # 0031371 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH #. ROOT CAUSE DESCRIPTION: A POTENTIAL ROOT CAUSE CAN BE ATTRIBUTED TO THE SYRINGE BARREL MOLDING. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580644 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 0031371 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Other