BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL CONVENIENCE TRAY EUROPE

    MDR report key: 8901095 · Received August 16, 2019

    Report

    Report Number
    3003152976-2019-00555
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    August 2, 2019
    Report Date
    September 4, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS WERE PROVIDED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A HAIR CAN BE OBSERVED INSIDE THE SYRINGE BARREL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1903357, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. ALL INDIVIDUALS ARE REQUIRED TO FOLLOW PROPER GOWNING PROCEDURES BEFORE ENTERING THE ROOM, INCLUDING HAIR PROTECTION. IT WAS DETERMINED THIS ISSUE WAS A RESULT OF PERSONNEL NOT FOLLOWING OUR OUTLINED GOWNING PROCEDURES. A PROJECT HAS BEEN INITIATED TO REDUCE FOREIGN MATTER WITHIN OUR PRODUCTS. PROJECT#(B)(4) OPEN TO REDUCE FOREIGN MATTER ON PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HAIR WAS FOUND IN THE SYRINGE 50ML LL CONVENIENCE TRAY EUROPE DURING USE AFTER DRAWING UP CALCIUM FOLINATE SOLUTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE EMPLOYEES IN OUR CYTOSTATIC DEPARTMENT FOUND A HAIR IN THE SYRINGE AFTER DRAWING CALCIUM FOLINATE SOLUTION INTO A BD PLASTIPAK".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.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 A HAIR WAS FOUND IN THE SYRINGE 50ML LL CONVENIENCE TRAY EUROPE DURING USE AFTER DRAWING UP CALCIUM FOLINATE SOLUTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE EMPLOYEES IN OUR CYTOSTATIC DEPARTMENT FOUND A HAIR IN THE SYRINGE AFTER DRAWING CALCIUM FOLINATE SOLUTION INTO A BD PLASTIPAK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694864 SYRINGE 50ML LL CONVENIENCE TRAY EUROPE SYRINGE FMF BECTON DICKINSON, S.A. 1903357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other