BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9306062 · Received November 11, 2019

    Report

    Report Number
    3002682307-2019-00603
    Event Type
    Malfunction
    Date Received
    November 11, 2019
    Date of Event
    October 25, 2019
    Report Date
    December 12, 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 BEEN PROVIDED WITH PHOTO FOR CATALOG 301942 LOT 1901146 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTO SHOWS THE LABEL WITH NO LOT NUMBER ON THE PRINTED LABEL. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD CONCLUDED THAT THE CAUSE OF THE PROBLEM WAS RELATED WITH SOME UNEXPECTED PROBLEM IN THE PRINTING MACHINE. AS A CONSEQUENCE, ONLY THE MIDDLE OF THE REPORTED SHELF CARTON LABEL WAS PRINTED. 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 LABEL ERROR OCCURRED WITH A SYRINGE S2 5ML 22GA 1-1/4IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NO LOT NUMBER ON THE MIDDLE PACKAGE." 100 OCCURRENCES REPORTED.

    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 LABEL ERROR OCCURRED WITH A SYRINGE S2 5ML 22GA 1-1/4IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NO LOT NUMBER ON THE MIDDLE PACKAGE." 100 OCCURRENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097484 SYRINGE S2 5ML 22GA 1-1/4IN SYRINGE FMF BECTON DICKINSON, S.A. 1901146

    Patients

    Seq Age Sex Outcome Treatment
    1 Other