BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 11803059 · Received May 10, 2021

    Report

    Report Number
    3003152976-2021-00255
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 12, 2021
    Report Date
    June 4, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: FOUR PHOTOS AND ONE SAMPLE WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, A WHITE FIBER WAS OBSERVED ON THE OUTSIDE OF THE SYRINGE BARREL. USING MAGNIFICATION THE FIBER WAS DETERMINED TO BE A POLYPROPYLENE FIBER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2010070, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. THE ASSEMBLY STATION HAS A DE-IONIZER AND VACUUM SYSTEM USED TO REMOVE ANY POLYPROPYLENE PARTICLES INSIDE THE BARREL. 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. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THE PARTICLES LIKELY GENERATED DURING THE MOVEMENT OF THE PRODUCT WITHIN THE MANUFACTURING EQUIPMENT. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER CLAIMS THAT ONE SYRINGE IN A CLOSED BLISTER CONTAINED THREADS. DUE TO THE BAD PHONE CONNECTION, IT WAS DIFFICULT TO GET ALL OTHER DETAILS BUT THE CUSTOMER WILL BE SENDING AS A PICTURE OF THE AFFECTED PRODUCT PER MAIL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER CLAIMS THAT ONE SYRINGE IN A CLOSED BLISTER CONTAINED THREADS. DUE TO THE BAD PHONE CONNECTION, IT WAS DIFFICULT TO GET ALL OTHER DETAILS BUT THE CUSTOMER WILL BE SENDING AS A PICTURE OF THE AFFECTED PRODUCT PER MAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697276 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2010070

    Patients

    Seq Age Sex Outcome Treatment
    1