BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPY-PHI DRUG DRAPE KIT

    MDR report key: 9188766 · Received October 14, 2019

    Report

    Report Number
    3012345110-2019-00009
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 18, 2019
    Report Date
    February 12, 2020
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    MMP
    PMA / PMN Number
    K041501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: "DRAPE ISN'T SEALED COMPLETELY" 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. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    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
    983333 SPY-PHI DRUG DRAPE KIT COVER, BARRIER, PROTECTIVE MMP STRYKER ENDOSCOPY-SAN JOSE 1906241

    Patients

    Seq Age Sex Outcome Treatment
    1