BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EYETEC

    MDR report key: 5867907 · Received August 11, 2016

    Report

    Report Number
    3011093388-2016-00001
    Event Type
    Malfunction
    Date Received
    August 11, 2016
    Date of Event
    March 9, 2016
    Report Date
    June 15, 2016
    Manufacturer
    NETWORK MEDICAL PRODCUCTS (USA) INC
    Product Code
    HOZ
    PMA / PMN Number
    K130117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INSPECTION: PRODUCT WAS RETURNED TO NMP-USA BY DISTRIBUTOR ((B)(4) FULL BOX, (B)(4) PARTIAL W/6 POUCHES). (B)(4) POUCHES WERE OPENED AND SPEARS EXAMINED DRY FOR FRAYED EDGES. THE NUMBER OF SPEARS PER POUCH WITH OBVIOUS EDGE FRAYING WAS QUANTIFIED. PHOTOS WERE TAKEN OF THE WORST EXAMPLE IN EACH POUCH. SPEARS WERE THEN SUBMERGED IN WATER AND RUBBED VIGOROUSLY BACK AND FORTH SEVERAL TIMES OVER A HARD SURFACE, TO EXAGGERATE ACTUAL USE. NO SPEARS FELL APART. SPEARS FROM (B)(4) ADDITIONAL LOTS SPANNING MANUFACTURING DATES FROM APRIL, 2014 TO DECEMBER, 2015 WERE EXAMINED IN THE SAME FASHION. NO SIGNIFICANT DIFFERENCES WERE NOTED IN QUANTITY OR DEGREE OF FRAYING. THE SUBJECT LOT WAS NOT UNUSUALLY FRAYED AS COMPARED WITH OTHER CELLULOSE LOTS. BATCH RECORDS OF THE SUSPECT LOT WERE CHECKED: FINAL INSPECTION FORM FOR THE SUSPECT LOT, DATED NOVEMBER 21, 2015, SHOWED NO ANOMALIES. INSPECTOR/PACKER TRAINED ON THE INSPECTION PROCEDURE ON APRIL 23, 2015. STERILISATION RECORDS CHECKED BY PRODUCTION MANAGER ON OCTOBER 30, 2015. DOSE EXPOSURE CONFIRMED, STERILISATION LOT NUMBER TRACED TO NMP PRODUCT REF AND LOT #S. STERILISATION COC SIGNED OCTOBER 30, 2015. SHIPMENT TO STERILISER PACKED BY PRODUCTION MANAGER ON SEPTEMBER 25, 2015, (B)(4) TRACED TO (B)(4). (B)(4) SPEARS, PRODUCTION DATES PRIOR TO AND INCLUDING SEPTEMBER 25, 2015, WERE PACKED BY TRAINED OPERATORS: OPERATOR 1 (TRAINED JUN.14,2014), OPERATOR 2 (AUGUST 21,2014), OPERATOR 3 (JULY 22, 2015), OPERATOR 4 (SEPTEMBER 10, 2015). (B)(4) SPEARS, PRODUCTION DATES PRIOR TO AND INCLUDING SEPTEMBER 25, 2015, CUT BY TRAINED OPERATORS: OPERATOR 1 (JUNE 30, 2014), OPERATOR 2 (SEPTEMBER 17, 2015). SPRIG SHIPMENTS (B)(4) RECEIVED AND INSPECTED BY PRODUCTION SUPERVISOR (TRAINED SEPTEMBER 29, 2015) AND FOUND TO BE ACCEPTABLE AND UNREMARKABLE. RAW MATERIAL LOT 110194, SHIPMENTS OF WHICH WERE RECEIVED AT NMP-USA JULY 24, AUGUST 12 AND SEPTEMBER 22, 2015. ALL LOTS INSPECTED BY SUPERVISOR PRODUCTION SUPERVISOR (TRAINED JUNE 30, 2015) AND FOUND TO BE ACCEPTABLE. A LEVEL OF PARTICULATE IS COMMON TO ALL SPEARS INDUSTRY WIDE. NO DEFICIENCIES IN PRODUCT QUALITY COULD BE IDENTIFIED. CONCLUSION - DEVICE WAS INAPPROPRIATELY USED (SURGICAL SITE INSUFFICIENTLY IRRIGATED). NO FURTHER ACTION PROPOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED END USER FEEDBACK FROM CUSTOMER MONTICELLO SURGERY VIA EMAIL THAT A PATIENT HAD TO HAVE ADDITIONAL SURGERY TO REMOVE A RETAINED PIECE OF CELLULOSE FOAM IN THE PATIENT'S EYE. NO INFORMATION WAS GIVEN ABOUT THE TYPE OF PROCEDURE CONDUCTED WITH THE CELLULOSE SPEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522262 EYETEC CELLULOSE SPEAR HOZ NETWORK MEDICAL PRODCUCTS (USA) INC 40-410-USA 15EST0128

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention