BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML 18G 1-1/2IN

    MDR report key: 10775415 · Received November 2, 2020

    Report

    Report Number
    2243072-2020-01775
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 8, 2020
    Report Date
    January 20, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 10/16/2020. H.6. INVESTIGATION: 1 SAMPLE WAS RETURNED TO SBDM. BASED ON IR ANALYSIS, THE FM IS SAME COMPONENT WITH RAW MATERIAL OF STOPPER (TALC). FROM INVESTIGATIONS, THE 20ML SYRINGE STOPPER COMPONENTS ARE INJECTED IN THE INJECTION MACHINE ON HIGH TEMPERATURE AND HIGH PRESSURE. IT IS LIKELY TPE (THERMO PLASTIC ELASTOMER, RAW MATERIAL OF 20ML SYRINGE STOPPER) BURR MAY BE FORMED IN THE HIGH PRESSURE WHILE INJECTION PROCESS. ALSO, THE BURR WAS SEPARATED IN THE SYRINGE ASSEMBLY PROCESS AND STOCKED IN THE SYRINGE TIP DUE TO STATIC ELECTRONICS WHILE SYRINGE ASSEMBLY MACHINE. SO, WE ASSUME THAT THE FM IS BURR OF STOPPER AND THE SYRINGE ASSEMBLY LINE INSPECTOR COULD NOT FIND THE FM AND IT CAUSED THIS COMPLAINT CASE. SBDM INSPECTED TOTAL 30 HOUSE SAMPLES OF THE COMPLAINT PRODUCT (SYRINGE 20ML 18G 1-1/2IN, LOT NO. 1003043, 1004073 & 1004212), THERE WAS NO DEFECTIVE PRODUCT FOUND IN THEM. SBDM REVIEW THE MANUFACTURING RECORD OF COMPLAINT SAMPLE (LOT NO. 1004073), THERE IS NO ISSUE WHILE MANUFACTURING. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 20ML 18G 1-1/2IN CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOREIGN MATTER IN SYRINGE TIP."

    Additional Manufacturer Narrative · 1

    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 20ML 18G 1-1/2IN CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOREIGN MATTER IN SYRINGE TIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240787 SYRINGE 20ML 18G 1-1/2IN PISTON SYRINGE FMF BECTON DICKINSON 1004073

    Patients

    Seq Age Sex Outcome Treatment
    1