BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPY-PHI PACK

    MDR report key: 9214462 · Received October 21, 2019

    Report

    Report Number
    3012345110-2019-00010
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    September 20, 2019
    Report Date
    February 19, 2020
    Manufacturer
    NOVADAQ TECHNOLOGIES
    Product Code
    MMP
    PMA / PMN Number
    K041501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: "SPY PHI DRAPE ISN'T SEALED CORRECTLY". PROBABLE ROOT CAUSE/S: REPORTED ISSUE IS LIKELY DUE TO A FAILURE OF THE BOTTOM POUCH SEAL. THIS SEAL IS APPLIED IN-HOUSE BY DRAPE OEM PREMIER GUARD AND OEM INVESTIGATION IS ONGOING TO DETERMINE ROOT CAUSE. NONCONFORMANCE PR# (B)(4) WAS OPENED TO DOCUMENT RESULTS OF INVESTIGATION AND DETERMINE ADDITIONAL ACTIONS. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION BUT THE REPORTED FAILURE MODE WAS CONFIRMED VIA INVESTIGATION FINDINGS FROM PR# (B)(4). 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 THE STERILE DRAPE WAS NOT SEALED COMPLETELY. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STERILE DRAPE WAS NOT SEALED COMPLETELY. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010957 SPY-PHI PACK COVER, BARRIER, PROTECTIVE MMP NOVADAQ TECHNOLOGIES 1906241

    Patients

    Seq Age Sex Outcome Treatment
    1