BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 10454897 · Received August 26, 2020

    Report

    Report Number
    1423395-2020-00021
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 28, 2020
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OJK
    UDI-DI
    10889942601752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS RECEIVED FOR OUR INVESTIGATION. WE RECEIVED ONE FULL, UNOPENED PACK FOR OUR INVESTIGATION. WE EXAMINED EACH ITEM WITHIN THE PACK FOR THE REPORTED DEBRIS. WE ALSO EXAMINED THE TRAY CONTAINING THE COTTON TIP APPLICATORS AND THE SYRINGES UNDER MAGNIFICATION. WE WERE UNABLE TO IDENTIFY PARTICULATE (FOREIGN OR COMPONENT RELATED) ON ANY OF THE ITEMS IN THE PACK. REVIEWED THE WORK ORDER AND THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED ISSUE. REVIEWED THE PACK BUILD HISTORY AND THE SYRINGES ARE PLACED INTO A POLY BAG INSIDE THE TRAY. INSIDE THE TRAY IS INSTRUMENT WIPES WITHIN RECLOSABLE BAGS, STERI DRAPE, EYE SPEARS WITHIN PACKAGING, EYE PADS WITHIN THE VENDOR PACKAGING, LABELS, MARKERS AND NEEDLES. THERE ARE LOOSE COTTON TIP APPLICATORS WITHIN A TRAY IN THE LAST FOLD OF THE PACK WHICH IS NOT RECOMMENDED, HOWEVER THEY ARE NOT IN CONTACT WITH THE AREA OF THE PACK CONTAINING THE SYRINGES SO TRANSFER THERE IS UNLIKELY. TRENDING: TRENDING WAS REVIEWED AND THERE HAVE BEEN 1 ADDITIONAL REPORTED COMPLAINT(S) FOR THIS ISSUE IN THE PAST 6 MONTHS. INVESTIGATION SUMMARY: THE ACCOUNT REPORTED FINDING FLECKS OF WHITE DEBRIS/SEDIMENT IN EYES. THE REPORTED ISSUE OCCURRED IN ITEM DYNJ44929C (LOT 20BDB783).WITH THE SAMPLE PROVIDED WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE AND DETERMINE A ROOT CAUSE AS THE PARTICULATE AND THE ORIGINAL SOURCE CANNOT BE IDENTIFIED. THIS COMPLAINT WAS CLOSED WITH CAUSE CODE: ZCD00006/UNCONFIRMED DEFECT; 0002/NOT CONFIRMED WITH RECEIVED SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CATARACT PROCEDURE, UPON INJECTION FLECKS OF DEBRIS AND SEDIMENT WAS INJECTED INTO THE PATIENT'S EYE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT ON (B)(6) 2020 DURING A CATARACT PROCEDURE, UPON INJECTION USING A 3 ML SYRINGE (A COMPONENT OF MEDLINE CATARACT PACK (DYNJ44929C) FLECKS OF DEBRIS, AND SEDIMENT WAS INJECTED INTO THE PATIENT'S EYE. THE REPORTER STATES, "THE DEBRIS WAS SUCCESSFULLY IRRIGATED OUT OF THE EYE AND PER ROUTINE ANTIBIOTICS WERE GIVEN." THE REPORTER STATES, "NO INJURY WAS DETECTED, NO CHANGE IN ROUTINE POST-OP CARE WAS INDICATED. THE REPORTER STATES, "PATIENT IS DOING BEAUTIFULLY." SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DUE TO THE NATURE OF THE REPORTED INCIDENT AND MEDICAL INTERVENTION PROVIDED THIS MEDWATCH IS BEING FILED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CATARACT PROCEDURE, UPON INJECTION FLECKS OF DEBRIS AND SEDIMENT WAS INJECTED INTO THE PATIENT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922330 MEDLINE INDUSTRIES, INC. DBD-CATARACT PACK OJK MEDLINE INDUSTRIES INC. DYNJ44929C 20BDB783 10889942601752

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention