BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL CLEAR 14GA 1-1/4IN

    MDR report key: 10112399 · Received June 2, 2020

    Report

    Report Number
    3002682307-2020-00175
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    April 17, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    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 REPORTED LOT 1904243, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. TEN RETAINED SAMPLES OF THE SAME LOT WERE USED FOR EVALUATION, NO DAMAGE OR MOLDING DEFECT OBSERVED. THROUGHOUT THE MANUFACTURING PROCESS, FORCE TESTING AND SILICONE CONTENT TESTS ARE CONDUCTED FOR EACH LOT. TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND ALL RESULTS FOR TESTS PERFORMED DURING MANUFACTURING, ALONG WITH THE RETAINED SAMPLES THAT WERE EVALUATED WERE FOUND TO BE WITHIN REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 50ML LL CLEAR 14GA 1-1/4IN LINE HAD DIFFICULTIES DURING USE AND CAUSED THE MACHINE TO GIVE REPEATED ALARMS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT DURING TREATMENT, ON (B)(6) 2020, THERE WERE PROBLEMS WITH THE SYRINGE LINE. WHEN THIS PROBLEM OCCURS IN CONNECTION WITH THE BD PLASTIKPAK SYRINGES, THE MACHINE GIVES REPEATED ALARMS. THE NURSES THEN CHANGED THE ENTIRE SYSTEM (SYRINGE AND SYRINGE LINE). THIS TROUBLESHOOTING OFTEN WORKS ON CERTAIN MACHINES BUT THERE ARE MACHINES THAT KEEP SHOWING UP WITH THIS PROBLEM - IT IS PRESENT THROUGHOUT THE THERAPY. THE REPORTER IS UNSURE ON WHETHER IT IS DUE TO THE MACHINES OR THE SYRINGES. THE PATIENT WAS INVOLVED, HOWEVER, THERE WAS NO PATIENT INJURY OR NEED FOR MEDICAL INTERVENTION REPORTED."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 50ML LL CLEAR 14GA 1-1/4IN LINE HAD DIFFICULTIES DURING USE AND CAUSED THE MACHINE TO GIVE REPEATED ALARMS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT DURING TREATMENT, ON (B)(6) 2020, THERE WERE PROBLEMS WITH THE SYRINGE LINE. WHEN THIS PROBLEM OCCURS IN CONNECTION WITH THE BD PLASTIKPAK SYRINGES, THE MACHINE GIVES REPEATED ALARMS. THE NURSES THEN CHANGED THE ENTIRE SYSTEM (SYRINGE AND SYRINGE LINE). THIS TROUBLESHOOTING OFTEN WORKS ON CERTAIN MACHINES BUT THERE ARE MACHINES THAT KEEP SHOWING UP WITH THIS PROBLEM - IT IS PRESENT THROUGHOUT THE THERAPY. THE REPORTER IS UNSURE ON WHETHER IT IS DUE TO THE MACHINES OR THE SYRINGES. THE PATIENT WAS INVOLVED, HOWEVER, THERE WAS NO PATIENT INJURY OR NEED FOR MEDICAL INTERVENTION REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571514 SYRINGE 50ML LL CLEAR 14GA 1-1/4IN SYRINGE FMF BECTON DICKINSON, S.A. 1904243

    Patients

    Seq Age Sex Outcome Treatment
    1 Other