BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGENCY C-SECTION BASIN

    MDR report key: 9818146 · Received March 11, 2020

    Report

    Report Number
    3005011024-2020-00002
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 13, 2020
    Report Date
    May 4, 2020
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    UDI-DI
    00749756909075
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: THE CAUTERY PENCIL CONTAINED IN THE CONVENIENCE KIT IS SUPPLIED TO DEROYAL BY CONMED. THEREFORE, A SUPPLIER CORRECTIVE ACTION REPORT (SCAR) WAS ISSUED TO CONMED. IN ITS RESPONSE, CONMED STATED IT WAS UNABLE TO IDENTIFY A ROOT CAUSE FOR THE REPORTED ISSUE BECAUSE A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. CORRECTIVE ACTION: A NEW ELECTRICAL TEST WAS IMPLEMENTED (B)(6) 2019 AS PART OF AN IMPROVEMENT. THE REPORTED LOT NUMBER FOR THE CAUTERY PENCIL WAS PRIOR TO THE IMPLEMENTATION OF THIS IMPROVED ELECTRICAL TEST. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING A HAND CAUTERY PENCIL INCLUDED WITHIN A CONVENIENCE KIT (PART 89-9429, LOT 5110378) WAS SPARKING DURING USE. A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE WORK ORDER FOR THE REPORTED FINISHED GOOD LOT WAS REVIEWED FOR ANY DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE BILL OF MATERIALS FOR THE CONVENIENCE KIT WAS REVIEWED AND THE AFFECTED COMPONENT WAS IDENTIFIED AS RAW MATERIAL 709124. THIS IS A CAUTERY PENCIL SUPPLIED TO DEROYAL BY CONMED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO CONMED. A RESPONSE WAS RECEIVED AND ACCEPTED APRIL 13, 2020 BY DEROYAL PERSONNEL. THE INVESTIGATION IS COMPLETE. IF NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    THE HAND CAUTERY IN A CONVENIENCE KIT SPARKED DURING USE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING A HAND CAUTERY PENCIL INCLUDED WITHIN A CONVENIENCE KIT (PART 89-9429, LOT 5110378) WAS SPARKING DURING USE. A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE WORK ORDER FOR THE REPORTED FINISHED GOOD LOT WAS REVIEWED FOR ANY DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE BILL OF MATERIALS FOR THE CONVENIENCE KIT WAS REVIEWED AND THE AFFECTED COMPONENT WAS IDENTIFIED AS RAW MATERIAL (B)(4). THIS IS A CAUTERY PENCIL SUPPLIED TO DEROYAL BY CONMED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO CONMED. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. THE INVESTIGATION IS ONGOING. WHEN NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE HAND CAUTERY IN A CONVENIENCE KIT SPARKED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278931 EMERGENCY C-SECTION BASIN KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES, INC. 89-9429 51100378 00749756909075

    Patients

    Seq Age Sex Outcome Treatment
    1