BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPY ELITE DRUG DRAPE KIT (SPY PAQ)

    MDR report key: 8529797 · Received April 18, 2019

    Report

    Report Number
    3012345110-2019-00004
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    March 20, 2019
    Report Date
    August 13, 2019
    Manufacturer
    NOVADAQ TECHNOLOGIES
    Product Code
    IZI
    UDI-DI
    10858701006268
    PMA / PMN Number
    K071619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: "LOOKS LIKE THE HOLE IS IN THE SEAM." POSSIBLE ROOT CAUSE: INVESTIGATION BY OEM MANUFACTURER ECOLAB COULD NOT CONFIRM THAT REPORTED ISSUE WAS CAUSED BY DEFICIENCIES OR DEVIATIONS IN THE MANUFACTURING PROCESS. REVIEW OF PROVIDED PHOTOGRAPHIC EVIDENCE COULD NOT CONFIRM THAT THE DEFECT WAS THE RESULT OF A SEALING ISSUE AND INSPECTION OF CURRENT DRAPE LOT INVENTORY COULD NOT FIND ADDITIONAL INSTANCES OF REPORTED ISSUE. OPERATORS WERE ALSO OBSERVED TO BE PERFORMING THE SEALING PROCESS IN ACCORDANCE WITH APPLICABLE WORK INSTRUCTIONS AND PRODUCT SPECIFICATIONS. OEM INDICATES THAT CAUSE IS POSSIBLY DUE TO THE END USER DRAPING TECHNIQUE. HOWEVER, THIS CANNOT BE CONFIRMED AS NO ADDITIONAL INFORMATION WAS AVAILABLE FROM CUSTOMER. AS A PRECAUTION, A QUALITY ALERT WAS POSTED IN THE OEM MANUFACTURING AREA AND APPLICABLE PERSONNEL WERE TRAINED FOR AWARENESS OF ISSUE. WHILE THE PICTURES FROM CUSTOMER FEEDBACK DO CONFIRM A FAILURE OF THE DRAPE, CAUSE OF ISSUE REMAINS UNKNOWN. THE PRODUCT WAS NOT RETURNED FOR OEM INVESTIGATION BUT THE REPORTED FAILURE MODE WAS CONFIRMED FROM PICTURES IN CUSTOMER FEEDBACK. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN. H3 OTHER TEXT : 81

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS BREACH IN STERILE BARRIER DUE TO HOLE IN THE SEAM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS BREACH IN STERILE BARRIER DUE TO HOLE IN THE SEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319040 SPY ELITE DRUG DRAPE KIT (SPY PAQ) ANGIOGRAPHIC X-RAY SYSTEM IZI NOVADAQ TECHNOLOGIES 19026 10858701006268

    Patients

    Seq Age Sex Outcome Treatment
    1