BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 9139732 · Received October 1, 2019

    Report

    Report Number
    3002682307-2019-00528
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 10, 2019
    Report Date
    November 7, 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
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED A SAMPLE OR PHOTO FOR CATALOG 301940 LOT 1901125 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, 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 THOUGH 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. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SYRINGE¿ WITH NEEDLE LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "DURING THE USE OF THE CLINICAL NURSE, THE SYRINGE TAKES THE LIQUID LEAKAGE , CAUSING THE CONTAMINATION OF THE LIQUID AND LOSING A NERVE GROWTH FACTOR OF THE MOUSE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SYRINGE¿ WITH NEEDLE LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "DURING THE USE OF THE CLINICAL NURSE, THE SYRINGE TAKES THE LIQUID LEAKAGE , CAUSING THE CONTAMINATION OF THE LIQUID AND LOSING A NERVE GROWTH FACTOR OF THE MOUSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937533 BD SYRINGE WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1901125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other