BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO PACK

    MDR report key: 11392890 · Received March 1, 2021

    Report

    Report Number
    3005011024-2021-00002
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    January 27, 2021
    Report Date
    April 14, 2021
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    OEQ
    UDI-DI
    00749756991889
    PMA / PMN Number
    ENFORCEMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: NO ROOT CAUSE WAS ESTABLISHED DUE TO THE LACK OF SAMPLE AND NO INFORMATION ON DURATION OF PROCEDURE. THE SPEC ALLOWS A PERCENTAGE OF STRIKETHROUGH. ONLY A PICTURE WAS SHARED FROM A TABLE WITH SOME REDDISH FLUID. CORRECTIVE ACTION: PER THE SCAR RESPONSE, O & M HALYARD MEDICAL STATED NO ROOT CAUSE WAS ESTABLISHED TO TAKE A CORRECTIVE ACTION. VERIFICATION WILL BE MEASURED THROUGH THE COMPLAINT SYSTEM. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED FOR A CONVENIENCE KIT (PART 89-10367, LOT 52924707) THAT CONTAINED AN ANGIO DRAPE THAT LEAKED DURING USE. A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE WORK ORDER FOR THE REPORTED FINISHED GOOD LOT WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE AFFECTED KIT COMPONENT WAS IDENTIFIED AS RAW MATERIAL 704411, WHICH IS SUPPLIED TO DEROYAL BY O & M HALYARD. THE RAW MATERIAL INVENTORY ON HAND WAS INSPECTED, BUT NO ISSUES WERE FOUND WITH THE AVAILABLE INVENTORY. DUE TO THE NATURE OF THE REPORTED ISSUE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO O & M HALYARD. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED. DUE TO EMPLOYEE OVERSIGHT, THIS REPORT IS BEING SUBMITTED OUTSIDE THE 30-DAY REQUIREMENT.

    Description of Event or Problem · 1

    AN ANGIO DRAPE CONTAINED WITHIN A CONVENIENCE KIT LEAKED URING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293982 ANGIO PACK ANGIOGRAPHY/ANGIOPLASTY KIT OEQ DEROYAL INDUSTRIES, INC. 89-10367 52924707 00749756991889

    Patients

    Seq Age Sex Outcome Treatment
    1