BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 18752881 · Received February 21, 2024

    Report

    Report Number
    1911916-2024-00122
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    February 14, 2024
    Report Date
    March 1, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028307
    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

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS FOREIGN MATTER BETWEEN THE SYRINGE AND THE PLUNGER. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THERE IS A STRING-LIKE PLASTIC FLASH OF BURNT PLASTIC ADHERED TO THE PLUNGER ROD. IT IS NOT LOOSE AND LOCATED AT THE BOTTOM OF THE PLUNGER ROD, RIGHT ABOVE THE RUBBER STOPPER. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR DURING THE 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT 2210055. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED THERE IS A FOREIGN MATERIAL BETWEEN THE SYRINGE AND THE PLUNGER.

    Description of Event or Problem · 0

    THERE IS A FOREIGN MATERIAL BETWEEN THE SYRINGE AND THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484645 SYRINGE 20ML LL S/C 48 SYRINGE, PISTON FMF BECTON DICKINSON 2210055 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown