BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 18921976 · Received March 18, 2024

    Report

    Report Number
    1911916-2024-00190
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    March 12, 2024
    Report Date
    April 11, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4).FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED A SYRINGE WAS FOUND WITH A DEVIATED PLUNGER. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE HAS A ROLLED RUBBER STOPPER. THE TWO PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THE RUBBER STOPPER WAS NOT PROPERLY PLACE IN THE FIXTURE DURING THE ASSEMBLY PROCESS. 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. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. 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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED STOPPER IS LOOSE. DURING NXT APS 24NL050666 NLGE-14637 "ASEPTIC PROCESS SIMULATION FOR NXT V1.2 PROCESS" 50ML SYRINGE WITH SAP MAT# 05126054, BATCH# 0001064494 AND SUPPLIER NAME "VWR INTERNATIONAL B.V." AND LOT# 1112019 WAS FOUND WITH A DEVIATED PLUNGER. THE SYRINGE WAS NOT USED DURING PROCESS AND WAS SEND OUT OF THE CLEANROOM FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    STOPPER IS LOOSE. DURING NXT APS 24NL050666 NLGE-14637 "ASEPTIC PROCESS SIMULATION FOR NXT V1.2 PROCESS" 50ML SYRINGE WITH SAP MAT# 05126054, BATCH# 0001064494 AND SUPPLIER NAME "(B)(4)." AND LOT# 1112019 WAS FOUND WITH A DEVIATED PLUNGER. THE SYRINGE WAS NOT USED DURING PROCESS AND WAS SEND OUT OF THE CLEANROOM FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212390 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 1112019 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown