BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 2ML 23GA 1-1/4IN BD

    MDR report key: 9355600 · Received November 21, 2019

    Report

    Report Number
    3002682307-2019-00619
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    April 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

    H.6. INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301940 LOT 1803120 TO INVESTIGATE FOR THIS RECORD. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. BD CONCLUDES THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED BECAUSE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE S2 2ML 23GA 1-1/4IN BD CHINA EXPERIENCED LEAKAGE WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOUND LEAK FROM THE PLUNGER ROD. THE LOT # PROVIDED BY CUTOMER IS 1803120.

    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 THE SYRINGE S2 2ML 23GA 1-1/4IN BD (B)(4) EXPERIENCED LEAKAGE WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOUND LEAK FROM THE PLUNGER ROD. THE LOT # PROVIDED BY CUSTOMER IS 1803120.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154166 SYRINGE S2 2ML 23GA 1-1/4IN BD SYRINGE FMF BECTON DICKINSON, S.A. 1803120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other