BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9274166 · Received November 4, 2019

    Report

    Report Number
    3002682307-2019-00588
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 25, 2019
    Report Date
    November 27, 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: BD HAS BEEN PROVIDED WITH A PHOTO FOR CATALOG 301940 LOT 1901125 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION FOR THE PHOTO SHOWS DAMAGED PRODUCT THAT SEEMS TO HAVE BEEN OPENED BEFORE ARRIVAL TO THE CUSTOMER. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. AFTER THE REVISION OF THE BATCH HISTORY REVIEW AND REGISTERS OF C-047 "REVISION OF DAMAGED MATERIAL IN HANDLING STORAGE PROCEDURES", BD HAS DETERMINED THAT NO RE-WORK WAS DONE WITH PRODUCT OF THIS BATCH. BD HAS NOT BEEN ABLE TO ESTABLISH THE SPECIFIC ROOT CAUSE THEREBY INCUR THE REPORTED ISSUE. THE MOST PROBABLY ROOT CAUSE COULD BE RELATED TO THE STORAGE OR TRANSPORT OF THE PRODUCT AFTER PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PACKAGING DAMAGE WAS FOUND BEFORE USE WITH SYRINGES S2 2ML 23GA 1-1/4IN. THE FOLLOWING. INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE COVER OF THE MIDDLE PACKAGE DAMAGED." 100 OCCURRENCES WERE 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 PACKAGING DAMAGE WAS FOUND BEFORE USE WITH SYRINGES S2 2ML 23GA 1-1/4IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE COVER OF THE MIDDLE PACKAGE DAMAGED." 100 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065210 SYRINGE S2 2ML 23GA 1-1/4IN SYRINGE FMF BECTON DICKINSON, S.A. 1901125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other