BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREE-PC.SYRINGES 2-30 ML, W.MOUNT.N

    MDR report key: 3841298 · Received May 19, 2014

    Report

    Report Number
    2523676-2014-00174
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Report Date
    May 9, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REF NUMBER (B)(4), LOT NUMBER UNK. REPORTS "THE ISSUE HAPPENED SEVERAL TIMES AND I ((B)(6)) MET WITH BOTH THE OPERATING ROOM GIRL AND THE DOCTOR DOING THE SURGERY. THE ONE INCIDENT DURING EYE SURGERY THEY HAD AN EXTENSION TUBE ON THE END WHICH IS NORMAL PROCEDURE AND WHEN THEY PUSHED THE SALINE THROUGH THE SYRINGE IT FLEW OFF INTO THE PATIENT'S EYE. THE REASON FOR THE ISSUE IS THAT THE PRESSURE TO PUSH SALINE THROUGH THE SYRINGE IS MUCH HARDER. IT'S NOT EASY TO PUSH AT ALL." REF MFR REPORT 9610825-2014-00174.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295993 THREE-PC.SYRINGES 2-30 ML, W.MOUNT.N SYRINGES FMF B. BRAUN MELSUNGEN AG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK