BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS SP120

    MDR report key: 12375568 · Received August 26, 2021

    Report

    Report Number
    3003152976-2021-00508
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    July 28, 2021
    Report Date
    October 18, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES OR PICTURES RECEIVED FOR INVESTIGATION. TEN RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, UPON VISUAL INSPECTION OF THE SAMPLES REQUESTED, NO DEFECTS CAN BE OBSERVED. THE TIP OF THE TEN SYRINGES OF EACH LOT DO NOT PRESENT ANY VISUAL DEFECT. FURTHER TESTING WAS CONDUCTED, NO SIGN OF LEAKAGE OCCURRED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2010081, 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. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED SYRINGE 1ML LS SP120 HAD CONNECTIVITY ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "POOR MATING OF SYRINGES AND NEEDLES BUBBLES WERE OBSERVED IN THE BARREL."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. INITIAL REPORTER ZIP: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED SYRINGE 1ML LS SP120 HAD CONNECTIVITY ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "POOR MATING OF SYRINGES AND NEEDLES BUBBLES WERE OBSERVED IN THE BARREL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271812 SYRINGE 1ML LS SP120 PISTON SYRINGE FMI BECTON DICKINSON, S.A. 2010081

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown