BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 12601862 · Received October 8, 2021

    Report

    Report Number
    3003152976-2021-00675
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    September 10, 2021
    Report Date
    November 8, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-11-04. H6: INVESTIGATION SUMMARY: SAMPLE AND PHOTOS RECEIVED FOR INVESTIGATION, WITH REFERENCE (B)(4) AND THREE POSSIBLE LOT NUMBERS WERE GIVEN: 210036, 2011094, 2103062. LOT NUMBER 210036 IS NOT VALID AS ONE NUMBER IS MISSING. UPON VISUAL INSPECTION, IT CAN BE OBSERVED A SYRINGE WITH A LONGITUDINAL CRACK ALONG THE BARREL THAT STARTS AT THE ROUND EDGE OF THE SYRINGE. NO OTHER DAMAGE CAN BE NOTICED IN THE PICTURE, LIKE TOUCHES OR HITS THAT COULD HAVE BEEN PRODUCED IN ASSEMBLY MACHINE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE POTENTIAL LOTS 2011094, 2103062 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL HAD A CRACKED BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD A BIZARRE INCIDENT WITH A 50ML SYRINGE FRACTURING DURING USE. "

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 50ML LL HAD A CRACKED BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD A BIZARRE INCIDENT WITH A 50ML SYRINGE FRACTURING DURING USE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498435 SYRINGE 50ML LL PISTON SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown