BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRIGATING CANNULA, STERILE

    MDR report key: 6057418 · Received October 26, 2016

    Report

    Report Number
    1064005-2016-00001
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    July 29, 2016
    Report Date
    August 22, 2016
    Manufacturer
    HURRICANE MEDICAL
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED THE USED 2030 CANNULA (LOT 160601) PRODUCT IN QUESTION ALONG WITH FORTY-THREE BOXES OF UNOPENED PRODUCT FROM THE SAME LOT. THE PRODUCT IN QUESTION WAS DIMENSIONALLY MEASURED AND FOUND THE DISTAL ANGLE LENGTH TO BE 3.97MM (TARGET VALUE 4.00MM); THE ANGLE TO BE 42 DEGREES (TARGET VALUE 45 DEGREES) STAINLESS STEEL TUBE OUTER DIAMETER 0.32MM (TARGET VALUE 0.30MM); AND STAINLESS STEEL TUBE INNER DIAMETER 0.15MM (TARGET VALUE 0.15MM). THE DIMENSIONAL ASPECTS OF THE PRODUCT IN QUESTION MET ALL REQUIRED SPECIFICATIONS AND DIMENSIONAL TOLERANCES OF THE DEVICE MASTER RECORD AND ENGINEERING DRAWING. THE TIP WAS NOT POINTED AS REPORTED BY THE SURGEON BUT RATHER CANNULATED AS DESIGNED. THE USED 2030 CANNULA (160601) PRODUCT IN QUESTION STAINLESS STEEL SURFACE WAS VIEWED AT 20X MAGNIFICATION AND FOUND THAT THE SILICONE SURFACE COATING WAS GONE AND APPEARED A BRIGHTER/LIGHTER FINISH WHEN COMPARED TO OTHER CANNULAS INSPECTED THAT CONTAINED THE SILICONE SURFACE COATING. THIS WOULD EXPLAIN WHY THE SURGEON MENTIONED THE PRODUCT IN QUESTION STAINLESS STEEL SURFACE VISUALLY APPEARED DIFFERENT AND APPEARED TO HAVE MORE FRICTION/TRACTION DURING USE. HURRICANE MEDICAL CANNULAS CONTAIN A SILICONE SURFACE COATING TO MINIMIZE FRICTION DURING USE. THE SILICONE SURFACE COATING IS APPLIED TO THE STAINLESS STEEL SURFACE AT THE TIME OF CANNULA ASSEMBLY. RE-PROCESSING THE CANNULA FOR REUSE MAY REMOVE THE SILICONE SURFACE COATING. HURRICANE MEDICAL CANNULAS ARE INTENDED FOR AND LABELED AS SINGLE USE ONLY. FIFTY UNOPENED AND RANDOMLY SELECTED PRODUCT 2030 CANNULA (160601) RETURNED FROM THE USER FACILITY WERE INSPECTED IN THE SAME MANNER AND VISUALLY INSPECTED FOR THE PRESENCE OF THE SILICONE SURFACE COATING. EACH DEVICE INSPECTED MET ALL SPECIFICATIONS OF THE DEVICE MASTER RECORD AND ENGINEERING DRAWING AND CONTAINED THE SILICONE SURFACE COATING. THE EXACT SAME RESULTS WERE OBTAINED WHEN ASSESSING FIFTY RANDOMLY SELECTED PRODUCT 2030 CANNULA FROM A DIFFERENT LOT (160602). THE RESULTS OF OUR INVESTIGATION STRONGLY SUGGEST THAT THE PRODUCT IN QUESTION WAS REUSED AND SILICONE SURFACE COATING WAS REMOVED DURING RE-PROCESSING. THIS IS CONSISTENT WITH THE SURGEON'S MADE OBSERVATIONS THAT THE STAINLESS STEEL SURFACE LOOKED DIFFERENT, THE CANNULA APPEARED TO HAVE MORE FRICTION/TRACTION DURING USE, AND IT INDUCED HYPHEMA IN 3 CONSECUTIVE CASES. THE CANNULA LOT (N2351) SIZE FOR THIS AND OTHER SIMILAR PRODUCTS WAS 140,000 UNITS AND ALL BEEN DISTRIBUTED TO OUR CUSTOMERS WORLDWIDE. THE APPLICABLE QUALITY ASSURANCE RECORDS INCLUDING RAW MATERIAL INSPECTION, IN-PROCESS MANUFACTURING INSPECTION, AND FINISHED MANUFACTURED GOODS FINAL INSPECTION DOCUMENTED THAT ALL RAW MATERIALS AND FINISHED PRODUCTS MET ALL THE SPECIFICATIONS OF THE DEVICE MASTER RECORDS AND ENGINEERING DRAWINGS. IN ADDITION. THERE HAVE BEEN NO OTHER COMPLAINTS OF THIS NATURE FOR THE PRODUCT IN QUESTION OR ANY OTHER HURRICANE MEDICAL CANNULA PRODUCTS IN THE HISTORY OF THE COMPANY. THE SURGEON CLAIMED THEY DO NOT REUSE CANNULAS, STATED THE FORTY-FOUR BOXES OF 2030 REPLACEMENT PRODUCTS (160701) WORK GREAT, AND VERIFIED THE THREE PATIENTS SUFFERED NO LONG TERM COMPLICATIONS AND ARE ALL DOING WELL.

    Description of Event or Problem · 1

    THE HURRICANE MEDICAL PRODUCT 2030, IRRIGATING CANNULA (LOT 160601) APPEARED SHORT AT THE DISTAL ANGLED END, HAVE SMALLER LUMEN AND APPEARED SHARPER AT THE TIP. IT ALSO APPEARED TO HAVE A DIFFERENT SURFACE FINISH, HAVE MORE FRICTION/TRACTION WITH THE CONTACTED TISSUES, IT INDUCED HYPHEMA IN 3 CONSECUTIVE CASES. THE SURGEON STATED THAT THE THREE PATIENTS SUFFERED NO LONG TERM COMPLICATIONS AND ARE ALL DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710514 IRRIGATING CANNULA, STERILE OPHTHALMIC CANNULA HMX HURRICANE MEDICAL 30G X 7/8" ANGLED 160601

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention