BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 12240760 · Received July 28, 2021

    Report

    Report Number
    1911916-2021-00738
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    June 29, 2021
    Report Date
    July 15, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. INITIAL REPORTER FACILITY: (B)(6). INVESTIGATION SUMMARY: IT WAS REPORTED THERE WERE DEFECTIVE, DISCOLORED AND LOOSE PARTICLES. TO AID IN THE INVESTIGATION, FIFTEEN SAMPLES IN SEALED PACKAGING BLISTERS AND TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND SEVEN SYRINGES SHOW DISCOLORATION OR EMBEDDED DEGRADED RESIN. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE TWO PHOTOS SHOW SOME OF THE SAMPLES RECEIVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 1091352. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS 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. ROOT CAUSE DESCRIPTION: THE EMBEDDED DEGRADED RESIN OCCURS AT THE STARTUP OF AN INJECTION MOLD/PRESS OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE SYSTEM OF THE TOOLING MOLD AND PRESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML LL TIP 1ML HAD FOREIGN MATTER WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED DEFECTIVE, DISCOLORED AND LOOSE PARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138182 SYRINGE 50ML LL TIP 1ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1091352 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1