BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL 120/PKG

    MDR report key: 10058133 · Received May 14, 2020

    Report

    Report Number
    3002682307-2020-00158
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    March 11, 2020
    Report Date
    July 17, 2020
    Product Code
    CAZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2001231, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. 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. A CAMERA SYSTEM HAS BEEN INSTALLED TO DETECT FOR MISSING OR IMPROPERLY ASSEMBLED STOPPERS, IMPROVEMENTS HAVE RECENTLY BEE MADE TO THIS SYSTEM, THE REPORTED LOT MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THOSE ENHANCEMENTS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 20ML LL 120/PKG STOPPER SEPARATED FROM THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE STOPPER GOT DISENGAGED WHEN PREPARING THE CHEMOTHERAPY. CLEAN OF THE WORK AREA. NO CONSEQUENCES FOR PATIENT AND USER."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 20ML LL 120/PKG STOPPER SEPARATED FROM THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE STOPPER GOT DISENGAGED WHEN PREPARING THE CHEMOTHERAPY. CLEAN OF THE WORK AREA. NO CONSEQUENCES FOR PATIENT AND USER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518380 SYRINGE 20ML LL 120/PKG ANESTHESIA SYRINGE CAZ 2001231

    Patients

    Seq Age Sex Outcome Treatment
    1 Other