BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30327 12CC SALINE SYRINGE {CAN} (10CC)

    MDR report key: 4131530 · Received October 1, 2014

    Report

    Report Number
    1282497-2014-00048
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 12, 2014
    Manufacturer
    CM AMERICAS
    Product Code
    NGT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BOX OF SAMPLES PRODUCT 8881570123, LOT 13H1604 WAS RECEIVED FOR EVALUATION. PHOTOGRAPHS OF THE BOX AND THE CONTENT WERE SENT TO THE SUPPLIER FOR ANALYSIS. THE SUPPLIER CONFIRMED THAT THE PHOTOGRAPHS AND THE SYRINGES IN THE BOX CORRESPOND TO THE LABEL ON THE BOX. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR LOT# 13H1604 WHICH WAS RELEASED ON AUGUST 13, 2013. THERE WERE NO MANUFACTURING RELATED ISSUES RELATED TO THE COMPLAINT ISSUED FOR THIS LOT. THE SYRINGES WERE FILLED AT 3 ML AS PER THE LABELS AND AS PER THE MANUFACTURING RECORDS OF LOT 13H1604. THE PRODUCT WAS PACKAGED PROPERLY. A ROOT CAUSE ANALYSIS DETERMINED THE MOST LIKELY ROOT CAUSES TO BE EITHER THE CUSTOMER EXPECTED 10 ML SYRINGES OR THAT THERE WAS A MISTAKE WHEN ORDERING OR THE WRONG PRODUCT WAS SHIPPED TO THE CUSTOMER. THERE IS NO CORRECTIVE OR PREVENTIVE ACTION PLANNED AT THIS TIME AS THIS PRODUCT WAS MANUFACTURED AND PACKAGED PROPERLY AT THE SUPPLIER. IF ADDITIONAL INFORMATION IS RECEIVED, THE INVESTIGATION WILL RESUME AS NEEDED. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/01/2014.AN INVESTIGATIN IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A PRE-FILL SYRINGE. THE CUSTOMER REPORTS THE PREFILL SYRINGES IN THE BOX WERE ONLY HALF FULL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611915 30327 12CC SALINE SYRINGE {CAN} (10CC) PREFILL SYRINGE NGT CM AMERICAS 8881570121 13H1604

    Patients

    Seq Age Sex Outcome Treatment
    1