BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OB OR C-SECTION PACK

    MDR report key: 11141190 · Received January 8, 2021

    Report

    Report Number
    3005011024-2020-00007
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    November 1, 2020
    Report Date
    March 23, 2021
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    UDI-DI
    00749756364300
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY A MEDWATCH (B)(4) WAS RECEIVED INDICATING A DRAPE CONTAINED WITHIN A CONVENIENCE KIT (PART 89-10567, LOT 52903818) ALLOWED FLUID TO LEAK. THIS WAS ENTERED AS AN INTERNAL COMPLAINT (B)(4). A SAMPLE WAS NOT RETURNED FOR EVALUATION. THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE BILL OF MATERIALS FOR THE FINISHED GOOD WAS REVIEWED TO IDENTIFY THE AFFECTED DRAPE COMPONENT. THERE ARE THREE DRAPES CONTAINED WITHIN THE CONVENIENCE KIT. THEREFORE, THE INITIAL REPORTER WAS CONTACTED TO IDENTIFY TO WHICH DRAPE THE REPORT REFERRED. AN INITIAL REQUEST WAS SENT DECEMBER 10 AND A FOLLOW UP REQUEST ON DECEMBER 28). AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. THE INVESTIGATION IS INCOMPLETE AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE IRRIGATION DRAPE IS SUPPLIED TO DEROYAL BY ADVANCE MEDICAL DESIGN, INC. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO ADVANCE MEDICAL DESIGN. IN ITS RESPONSE, THE SUPPLIER STATED THE ROOT CAUSE IS UNKNOWN. THEY WERE UNABLE TO IDENTIFY ANY DAMAGES OR LEAKS IN THE DEVICE. CORRECTIVE ACTION: PER ITS SCAR RESPONSE, ADVANCED MEDICAL DESIGN STATED ITS INCOMING INSPECTION WILL BE INCREASED TO SAMPLE A LARGER INCOMING SAMPLE SIZE. IF THERE IS AN ISSUE WITH THE DRAPES, A LARGER SAMPLE SIZE SHOULD IDENTIFY THE ISSUE AT INCOMING. INVESTIGATION SUMMARY A MEDWATCH (REPORT (B)(4) WAS RECEIVED INDICATING A DRAPE CONTAINED WITHIN A CONVENIENCE KIT (PART 89-10567, LOT 52903818) ALLOWED FLUID TO LEAK. THIS WAS ENTERED AS AN INTERNAL COMPLAINT ((B)(4)). A SAMPLE WAS NOT RETURNED FOR EVALUATION. CLARIFICATION WAS REQUESTED AS TO WHERE THE DRAPE WAS LEAKING. HOWEVER, THE INITIAL REPORTER STATED NO ADDITIONAL INFORMATION WAS AVAILABLE. THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE BILL OF MATERIALS FOR THE FINISHED GOOD WAS REVIEWED TO IDENTIFY THE AFFECTED DRAPE COMPONENT. THERE ARE THREE DRAPES CONTAINED WITHIN THE CONVENIENCE KIT. THEREFORE, THE INITIAL REPORTER WAS CONTACTED TO IDENTIFY TO WHICH DRAPE THE REPORT REFERRED. AN INITIAL REQUEST WAS SENT DECEMBER 10 AND A FOLLOW UP REQUEST ON DECEMBER 28. ON DECEMBER 29, CONFIRMATION WAS RECEIVED THAT THE AFFECTED DRAPE WAS RAW MATERIAL (B)(4), WHICH IS AN IRRIGATION DRAPE SUPPLIED BY ADVANCE MEDICAL DESIGN. A SCAR WAS ISSUED TO ADVANCE MEDICAL DESIGN. A RESPONSE WAS RECEIVED JANUARY 14, 2021 AND ACCEPTED BY DEROYAL PERSONNEL. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE DRAPE INCLUDED IN THE CONVENIENCE KIT DOES NOT WORK PROPERLY. IT CONTINUES TO ALLOW FLUID TO LEAK OUT, COMPROMISING STERILITY.

    Description of Event or Problem · 1

    THE DRAPE INCLUDED IN THE CONVENIENCE KIT DOES NOT WORK PROPERLY. IT CONTINUES TO ALLOW FLUID TO LEAK OUT, COMPROMISING STERILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35437 OB OR C-SECTION PACK KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES, INC. 89-10576 52903818 00749756364300

    Patients

    Seq Age Sex Outcome Treatment
    1