BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3-PIECE SYRINGE

    MDR report key: 14748381 · Received June 20, 2022

    Report

    Report Number
    3003152976-2022-00282
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    May 24, 2022
    Report Date
    July 27, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2203076, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DEFECTS WERE IDENTIFIED. 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. GIVEN NO ISSUES WERE OBSERVED WITH THE RETAINED SAMPLES AND THE DEVICE HISTORY RECORDS DO NOT INDICATE ANY ISSUES RELATED TO THIS INCIDENT, WE CANNOT IDENTIFY A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 3-PIECE SYRINGE SCALE MARKING ARE LIGHT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE ARE ONLY A FEW GRADUATION MARKS WITH LIGHT (ALMOST NOT VISIBLE) PRINTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 3-PIECE SYRINGE SCALE MARKING ARE LIGHT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE ARE ONLY A FEW GRADUATION MARKS WITH LIGHT (ALMOST NOT VISIBLE) PRINTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090149 BD PLASTIPAK¿ 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2203076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown