BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML 22GA 1-1/4IN

    MDR report key: 9371143 · Received November 25, 2019

    Report

    Report Number
    3002682307-2019-00634
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    May 30, 2019
    Report Date
    December 16, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301942 LOT 1811184 TO INVESTIGATE FOR THIS RECORD. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. DESPITE THE FACT THAT ANY HIGH VOLUME MANUFACTURING PROCESS MAY GENERATE SOME PARTICULATE MATTER, THE HIGHLY CAPABLE PROCESS EMPLOYED BY BD TO PRODUCE DISCARDIT SYRINGES KEEPS PARTICULATE MATTER TO EXTREMELY LOW LEVELS THROUGH STRINGENT MANUFACTURING PROCESSES AND ENVIRONMENTAL CONTROLS. THE WHOLE PROCESS TO ASSEMBLY AND PACKAGE THE PRODUCT TAKES PLACE IN AN ENVIRONMENTAL CONTROLLED ROOM WHERE THE AIR IS CONTINUOUSLY FILTERED USING A HEPA FILTER SYSTEM AND THERE ARE SEVERAL STRICT MEASURES. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A SYRINGE S2 5ML 22GA 1-1/4IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "FOUND FOREIGN MATTER ON THE TIP OF BARREL."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A SYRINGE S2 5ML 22GA 1-1/4IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "FOUND FOREIGN MATTER ON THE TIP OF BARREL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168133 SYRINGE S2 5ML 22GA 1-1/4IN SYRINGE FMF BECTON DICKINSON, S.A. 1811184

    Patients

    Seq Age Sex Outcome Treatment
    1 Other