BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 11056145 · Received December 22, 2020

    Report

    Report Number
    3003152976-2020-00575
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 23, 2020
    Report Date
    January 27, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    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: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2003232, FINDING ONE ANNOTATION THAT COULD BE RELATED TO THE REPORTED EVENT. DURING THE ASSEMBLY PROCESS, BURNT TIPS WERE DETECTED DURING THE SHELF-CONTROL INSPECTION. THE ASSEMBLY LINE WAS CLEANED AND ALL IMPACTED UNITS DETECTED WERE DISCARDED. TEN RETAINED SAMPLES OF THE SAMPLE LOT WERE USED FOR ADDITIONAL INVESTIGATION. ALL PRODUCT WAS VISUALLY INSPECTED, NO FOREIGN MATTER WAS OBSERVED ANYWHERE ON THE PRODUCT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. IT IS POSSIBLE THIS INCIDENT IS RELATED TO THE FAILURE DETECTED DURING MANUFACTURING, WITHOUT THE PHYSICAL SAMPLE TO EVALUATE WE CANNOT VERIFY THIS AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A BLACK DEPOSIT AT THE TIP OF THE SYRINGE THAT MIGRATES INSIDE WHEN MEDICINE IS TAKEN. 09DEC2020: TW NOTICE SENT REQUESTING SAMPLE STATUS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML LL CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A BLACK DEPOSIT AT THE TIP OF THE SYRINGE THAT MIGRATES INSIDE WHEN MEDICINE IS TAKEN. 09DEC2020: TW NOTICE SENT REQUESTING SAMPLE STATUS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519959 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2003232

    Patients

    Seq Age Sex Outcome Treatment
    1