BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOELASTIC CANNULA

    MDR report key: 3955097 · Received July 23, 2014

    Report

    Report Number
    1064005-2014-00002
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    March 25, 2014
    Report Date
    July 11, 2014
    Manufacturer
    HURRICANE MEDICAL
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN QUESTION WAS NOT AVAILABLE FOR INSPECTION, THEREFORE, (B)(4) SUBSTANTIALLY EQUIVALENT FINISHED 2227 (LOT 140601) WERE USED IN OUR INVESTIGATION. EACH PRODUCT WAS INDIVIDUALLY ATTACHED TO A 6% LUER LOCK SYRINGE AND THEN THE PROTECTIVE PLASTIC SHEATH WAS HAND REMOVED IN AN ACTUAL USE FASHION. THE PLASTIC PROJECTIVE SHEATHS WERE THEN INSPECTED UNDER 10X MAGNIFICATION FOR CRACKS AND BROKEN PORTIONS AND IN ALL INSTANCES NO CRACKS OR BROKEN PORTIONS WITHIN THE SHEATH WAS OBSERVED. THE PRODUCTS WERE QUALITY INSPECTED AND MET ALL THE REQUIREMENTS OF THE APPLICABLE DEVICE MASTER RECORD AND ENGINEERING DRAWING. THE CANNULA RAW MATERIAL LOT NUMBER IN QUESTION TOTALED (B)(4)CANNULAS WITH PLASTIC PROTECTIVE SHEATHS AND OF THAT (B)(4) PRODUCT 2227 (LOT 130902) WERE MANUFACTURED AND DISTRIBUTED TO CUSTOMERS WORLDWIDE. THE APPLICABLE QUALITY ASSURANCE RECORDS INCLUDING RAW MATERIAL INSPECTION AND FINISHED MANUFACTURED GOODS INSPECTION DOCUMENTED THAT ALL RAW MATERIALS AND FINISHED PRODUCTS MET ALL THE SPECIFICATIONS OF THE APPLICABLE DEVICE MASTER RECORD AND ENGINEERING DRAWING. IN ADDITION, THERE HAVE BEEN NO OTHER COMPLAINTS OF THIS NATURE REGARDING A BROKEN PROTECTIVE SHEATH DURING USE, FOR ANY HURRICANE MEDICAL PRODUCTS IN THE HISTORY OF THE COMPANY. THEREFORE, THIS IS BELIEVED TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE PRODUCT'S PROTECTIVE PLASTIC SHEATH FRACTURED WHILE HANDLING AND THE SURGEON CUT A FINGER ON THEIR RIGHT HAND. THIS ADVERSE INCIDENT OCCURRED (B)(6) 2014 BUT WAS NOT REPORTED TO HURRICANE MEDICAL UNTIL (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431645 VISCOELASTIC CANNULA OPHTHALMIC CANNULA HMX HURRICANE MEDICAL 27G X 7/8", ANGLED 130902

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention