BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE

    MDR report key: 12017997 · Received June 17, 2021

    Report

    Report Number
    1937141-2021-00012
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 20, 2021
    Report Date
    July 29, 2021
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    UDI-DI
    20812496011514
    PMA / PMN Number
    K960581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXTERNAL LAB EVALUATED THE RETURNED UNIT AND DETERMINED THAT THE DISCOLORED AREA OBSERVED BY THE CUSTOMER WAS LOCATED ON THE EXTERIOR OF THE BAG. NO DISCOLORATION OR STAIN WAS FOUND ON THE INTERIOR OF THE BAG. THE EXTERNAL LAB FURTHER DETERMINED THE DISCOLORED AREA CONSISTED OF A DARK PARTICLE DEPOSITED ON THE SURFACE OF THE BAG. THE PARTICLE WAS ANALYZED AND FOUND TO BE A CHARRED ORGANIC SUBSTANCE. THE PARTICLE WAS ACCOMPANIED BY SCRAPE MARKS ON THE EXTERIOR OF THE BAG WHICH SUGGESTS THE PARTICLE WAS DEPOSITED DURING AN ABRASION EVENT. A SOURCE FOR THE CHARRED ORGANIC MATERIAL COULD NOT BE IDENTIFIED WITHIN THE MANUFACTURING PROCESS. AS THE UNIT WAS FILLED BY THE PHARMACY, IT IS POSSIBLE THE ABRASION EVENT OCCURRED DURING THE USE OF THE DEVICE. AS THE STAIN WAS CONFIRMED TO BE ON THE EXTERIOR OF THE UNIT, THERE IS NO ASSESSED RISK TO THE HEALTH. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION WAS DONE ON THE RETURNED UNIT AND A DISCOLORED AREA WAS CONFIRMED WITHIN THE UPPER CHAMBER OF THE FILLED BAG. THE UNIT WAS SENT TO AN EXTERNAL LAB FOR ANALYSIS AND THE RESULTS ARE PENDING. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE QUALITY CONTROL INSPECTION OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STAIN WAS EMBEDDED INSIDE THE LIPID CHAMBER OF A SECURE EVA DUAL CHAMBER 3000 ML BAG WITH 5 PORT MANIFOLD FILL SET. THE STAIN WAS NOTED IN THE FILLED BAG BY THE PHARMACY DURING THE PACKING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918299 SECURE 3000 ML EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET KPE THE METRIX COMPANY 66631 66631-A6718 20812496011514

    Patients

    Seq Age Sex Outcome Treatment
    1