BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 11752484 · Received April 30, 2021

    Report

    Report Number
    1423395-2021-00021
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    March 17, 2021
    Report Date
    June 1, 2021
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OJK
    UDI-DI
    10889942872398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D9 DEVICE AVAILABLE FOR EVALUATION -N/A G6 TYPE OF REPORT - FOLLOW-UP. H2 IF FOLLOW-UP WHAT TYPE? ADDITIONAL INFORMATION. H3 DEVICE EVALUATED BY MANUFACTURER - N/A H6 TYPE OF INVESTIGATION- 3331, 4110, 4112, 4119 H5 INVESTIGATION CONCLUSION - ZCD00005/DEFECT CONFIRMED: UNKNOWN RESPONSIBLE PARTY H10 INVESTIGATION REPORT READS AS FOLLOWS: 05/11/2021 15:26:40 CST ((B)(6) ). "SAMPLE EVALUATION: A PHOTO WAS RECEIVED FOR OUR INVESTIGATION. PHOTO SHOWS A LONG FIBER / THREAD FOUND IN EYE UNDER MAGNIFICATION. CANNOT IDENTIFY THE PARTICULATE IS BLUE. NOT CERTAIN WHEN PHOTO WAS TAKEN DURING OR POST-SURGERY. FINISHED GOOD PRODUCTION RECORDS REVIEWED: REVIEW OF PRODUCTION ASSEMBLY INSTRUCTIONS SHOWS 20-GAUGE NEEDLE, EYE SPEARS AND INSTRUMENT WIPE ARE LEFT INSIDE OF VENDORS PACKAGING. SYRINGES AND TEGA-DERM ARE PLACED WITH COMPONENTS INSIDE OF A POLY BAG. THERE IS NO DIRECT CONTACT WITH DRAPES, GOWNS OR LINER OF LOW LINT BTC. NO COTTON TOWELS ARE USED IN PACK. WITHOUT LOT INFORMATION FOR PACK, WE CANNOT PULL OR REVIEW PRODUCTION RECORDS. FINISHED GOOD PACK BUILD REVIEWED: REVIEW OF THE BOM SHOWS A LOW LINT BTC IS USED FOR THIS PACK. 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 BLUE FIBERS IN THE PACK. THE REPORTED ISSUE OCCURRED IN ITEM VAL009CATEA (LOT UNKNOWN). BASED ON THE PHOTO AND INFORMATION IN THIS COMPLAINT WE WERE ABLE TO DETERMINE A TRUE ROOT CAUSE AS THE ORIGINAL SOURCE OF THE PARTICULATE COULD NOT BE IDENTIFIED."

    Description of Event or Problem · 0

    IT WAS REPORTED, "BLUE FIBERS IN THE CUSTOM PACK ARE EVIDENT ON THE INSTRUMENTS WITHIN THE PACK. FIBERS HAVE BEEN FOUND IN THE EYE AS WELL." SPECIFICALLY MENTIONED, "IT WAS INSIDE THE EYE, ON TOP OF THE LENS AND WAS REMOVED WITH UTRADA FORCEPS, 3/17/21 BY MD."

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED, "BLUE FIBERS IN THE CUSTOM PACK ARE EVIDENT ON THE INSTRUMENTS WITHIN THE PACK. FIBERS HAVE BEEN FOUND IN THE EYE AS WELL." SPECIFICALLY MENTIONED, "IT WAS INSIDE THE EYE, ON TOP OF THE LENS AND WAS REMOVED WITH UTRADA FORCEPS, (B)(6) 2021 BY MD." ADDITIONAL EMAILS RECEIVED BY FACILITY REPRESENTATIVES, (B)(6), WHO PROVIDED ADDITIONAL INFORMATION IN REGARDS TO THIS REPORTED INCIDENT. REPORTERS CONFIRM INCIDENT OCCURRED (B)(6) 2021. REPORTER STATES, "PRODUCT WAS NOT THOROUGHLY INSPECTED PRIOR TO USE; ISSUE WAS IDENTIFIED DURING PROCEDURE." "PHYSICIAN NOTICED LINT IN PATIENT'S EYE AND ON INSTRUMENTS." PER INITIAL COMPLAINT REPORT, LINT REMOVED WITH UTRADA FORCEPS BY PHYSICIAN THAT DAY ((B)(6) 2021). REPORTER STATES, "NO SERIOUS INJURY, FOLLOW-UP CARE OR MEDICAL INTERVENTION NEEDED." NO ADDITIONAL GENERAL ANESTHESIA OR SEDATION WAS NEEDED OR PROVIDED AFTER THE REPORTED INCIDENT. REPORTER STATES, "NO ADVERSE EVENTS REPORTED DURING POST-OP PHONE CALL." NO SAMPLES ARE AVAILABLE FOR RETURN AND EVALUATION. PHOTOGRAPH SENT. NO FURTHER INFORMATION HAS BEEN PROVIDED. DUE TO THE REPORTED INCIDENT, MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "BLUE FIBERS IN THE CUSTOM PACK ARE EVIDENT ON THE INSTRUMENTS WITHIN THE PACK. FIBERS HAVE BEEN FOUND IN THE EYE AS WELL." SPECIFICALLY MENTIONED, "IT WAS INSIDE THE EYE, ON TOP OF THE LENS AND WAS REMOVED WITH UTRADA FORCEPS, (B)(6) 2021 BY MD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654750 MEDLINE INDUSTRIES, INC. CATARACT TENAYA SURGERY CENTER OJK MEDLINE INDUSTRIES INC. VAL009CATEA 10889942872398

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention