BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE

    MDR report key: 15341463 · Received September 1, 2022

    Report

    Report Number
    3003152976-2022-00400
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    August 9, 2022
    Report Date
    August 17, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. DAMAGE TO THE BARREL CAN OCCUR DUE TO THE PRODUCT JAMMING WITHIN THE MANUFACTURING EQUIPMENT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2101083, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED DURING MANUFACTURING. BASED ON THE AVAILABLE INFORMATION WE CANNOT IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD 20 ML SYRINGE EXPERIENCED A CRACK IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRACK IN 20ML SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137928 BD 20 ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2101083

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown