BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE SOLOMED 2PC 2ML 25X5/8 FIXED CN

    MDR report key: 8846642 · Received July 31, 2019

    Report

    Report Number
    3002682307-2019-00423
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    June 27, 2019
    Report Date
    August 29, 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 302772 LOT 1801406 TO INVESTIGATE FOR THIS RECORD. BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. THE 20 REFERENCE UNITS THAT HAVE BEEN RETAINED AND ANALYZED FOR THIS RECORD SHOWED NO DIFFICULTIES OR DEFECTS. IN ADDITION, THE PACKAGE INTEGRITY HAS BEEN WITHIN SPECIFICATIONS. AS THIS IS THE FIRST TIME THIS LOT HAS BEEN REPORTED, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. DHR: BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S H3 OTHER TEXT .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE IT WAS DISCOVERED THAT STERILITY WAS COMPROMISED DUE TO POOR SEAL INTEGRITY WITH A BD SYRINGE SOLOMED 2PC 2ML 25X5/8 FIXED CN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BEFORE USE, IT'S NOTICED THAT THE PACKAGE SEAL INTEGRITY POOR.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 PRIOR TO USE IT WAS DISCOVERED THAT STERILITY WAS COMPROMISED DUE TO POOR SEAL INTEGRITY WITH A BD SYRINGE SOLOMED 2PC 2ML 25X5/8 FIXED (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: BEFORE USE, IT'S NOTICED THAT THE PACKAGE SEAL INTEGRITY POOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640819 BD SYRINGE SOLOMED 2PC 2ML 25X5/8 FIXED CN SYRINGE FMF BECTON DICKINSON, S.A. 1801406

    Patients

    Seq Age Sex Outcome Treatment
    1 Other