BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 19058430 · Received April 8, 2024

    Report

    Report Number
    1911916-2024-00241
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 21, 2024
    Report Date
    April 5, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR WITH DEVICE EVALUATION. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. IT WAS REPORTED A SYRINGE WAS FUND WITH A DEVIATED PLUNGER. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE COMPLETED. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE WITH NO PACKAGING BLISTER AND A ROLLED STOPPER. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR DURING THE ASSEMBLY PROCESS IF THE PLUNGER ROD WAS NOT CENTERED TO THE POSITION OF THE RUBBER STOPPER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 1112019. 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. VERIFICATION OF THE ASSEMBLY PROCESS WAS PERFORMED. THE SETTINGS OF THE PLUNGER ROD -RUBBER STOPPER ASSEMBLY PROCESS WAS CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE

    Description of Event or Problem · 0

    ATERIAL 05126054 "50ML SYRINGE" WAS FOUND WITH DEVIATED PLUNGER DURING NXT APS 24NL050666 NLGE-14637 "ASEPTIC PROCESS SIMULATION FOR NXT V1.2 PROCESS" 50ML SYRINGE WITH SAP MAT# 05126054, BATCH# 0001064494 AND LOT# 1112019 WAS FOUND WITH A DEVIATED PLUNGER (REFER TO ATTACHMENT #1). THE SYRINGE WAS NOT USED DURING PROCESS AND WAS SEND OUT OF THE CLEANROOM FOR FURTHER INVESTIGATION. WHEN DURING NXT APS 24NL050666 ON 05-MAR-24/ DEVIATED PLUNGER WAS OBSERVED IN THE SYRINGE BEFORE USE IN PROCESS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108592 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 1112019 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown