BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL CLEAR 14GA 1-1/4IN

    MDR report key: 10279749 · Received July 15, 2020

    Report

    Report Number
    3002682307-2020-00218
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 24, 2020
    Report Date
    August 11, 2020
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?: YES. RETURNED TO MANUFACTURER ON: 7/22/2020. INVESTIGATION: TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR MOLDING DEFECT WAS OBSERVED ON THE PLUNGER ROD OR ANY OTHER COMPONENTS THAT COULD CONTRIBUTE TO THE REPORTED LEAK AND THE STOPPER WAS PROPERLY ASSEMBLED ONTO THE PLUNGER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 1904243 AND 1904244, NO DEVIATIONS OR NON-CONFORMANCE'S WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. LEAKAGE TESTING WAS PERFORMED ON THE SAMPLES AND ALL PRODUCT MET REQUIRED SPECIFICATION, NO LEAKAGES WERE OBSERVED. 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. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 50ML LL CLEAR 14GA 1-1/4IN LEAKED MEDICATION PAST THE STOPPER AND BETWEEN THE PLUNGER ROD AND BARREL. LOT#'S 1904243 AND 1904244 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN DRAWING UP MEDICATION, THE LIQUID COMES OUT THROUGH THE BACK. THE LIQUID FLOWS THROUGH THE RUBBER SEAL AND FLOWS BETWEEN THE PLUNGER ROD AND THE BARREL. THIS HAS NOT BEEN OBSERVED WHEN USING PUMPS, ONLY WHEN DRAWING UP MEDICATION."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1904243, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-04-03, MEDICAL DEVICE LOT #: 1904244, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-04-08. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 50 ML LL CLEAR 14 GA 1-1/4 IN LEAKED MEDICATION PAST THE STOPPER AND BETWEEN THE PLUNGER ROD AND BARREL. LOT# 1904243 AND 1904244 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN DRAWING UP MEDICATION, THE LIQUID COMES OUT THROUGH THE BACK. THE LIQUID FLOWS THROUGH THE RUBBER SEAL AND FLOWS BETWEEN THE PLUNGER ROD AND THE BARREL. THIS HAS NOT BEEN OBSERVED WHEN USING PUMPS, ONLY WHEN DRAWING UP MEDICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739854 SYRINGE 50ML LL CLEAR 14GA 1-1/4IN PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other