BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE WITH NEEDLE

    MDR report key: 9587719 · Received January 14, 2020

    Report

    Report Number
    3002682307-2019-00722
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 24, 2019
    Report Date
    March 10, 2020
    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: BD HAS BEEN PROVIDED WITH PHOTOS AND THE AFFECTED SAMPLE FOR CATALOG 301948 LOT 1901137 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE SAMPLE IDENTIFIES THE FOREIGN MATTER AS GREASE ALLOCATED BETWEEN THE BARREL AND PLUNGER. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE PRESENCE OF THIS GREASE CONTAMINATION WAS DUE TO AN INCORRECT USE OF IT DURING THE ASSEMBLY MACHINE MAINTENANCE PROCESS. AN INCORRECT PRACTICE DURING THIS MAINTENANCE ALLOWED THE PRESENCE OF THIS GREASE IN THE MACHINE WHICH FINALLY ENDED INSIDE THE SYRINGE. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD¿ 20 ML SYRINGE WITH NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ON (B)(6) 2019, A COMPLAINT WAS RECEIVED FROM HEAD NURSE OF THE SUPPLY ROOM OF WEST CHINA HOSPITAL, WHICH REFLECTED THAT THE MATERIAL NO.301948 SYRINGE HAD MILDEW. THE INFORMATION OF ABOUT ONE DISPOSABLE STERILE SYRINGE INVOLVED IN THE COMPLAINT WAS MATERIAL NO. 301948, BATCH NO. 1901137, AND THE PERIOD OF VALIDITY WAS (B)(6) 2023."

    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 FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD¿ 20 ML SYRINGE WITH NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ON (B)(6) 2019, A COMPLAINT WAS RECEIVED FROM HEAD NURSE OF THE SUPPLY ROOM OF WEST CHINA HOSPITAL, WHICH REFLECTED THAT THE MATERIAL NO.301948 SYRINGE HAD MILDEW. THE INFORMATION OF ABOUT ONE DISPOSABLE STERILE SYRINGE INVOLVED IN THE COMPLAINT WAS MATERIAL NO. 301948, BATCH NO. 1901137, AND THE PERIOD OF VALIDITY WAS 2023.12.31."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52677 BD 20 ML SYRINGE WITH NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1901137

    Patients

    Seq Age Sex Outcome Treatment
    1 Other