BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST PREP KIT DRY LATEX SAFE 20C

    MDR report key: 12698579 · Received October 26, 2021

    Report

    Report Number
    3005011024-2021-00014
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    October 4, 2021
    Report Date
    November 17, 2021
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    UDI-DI
    00749756150149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER WELMED INC. ROOT CAUSE: THE SUPPLIER WELMED INC. HAS DETERMINED THAT THEIR STANDARD OPERATING PROCEDURES DID NOT SPECIFY THE DISPOSAL METHOD OF THE PRODUCT DURING THE MACHINE COMMISSIONING PERIOD. THE FOLLOWING CORRECTIVE ACTIONS HAVE TAKEN PLACE BY THE SUPPLIER WELMED INC: QUALITY ASSURANCE CHECKED THE EQUIPMENT PARAMETERS OF THE ON-SITE WELDING MACHINE AND FOUND THE EQUIPMENT PARAMETERS WERE IN COMPLIANCE WITH THE VERIFICATION DOCUMENTS. SUPPLIER CONDUCTED CONTAINMENT AND TENSILE TESTS ON THE PRODUCTS IN THE INVENTORY, NO ISSUES WERE FOUND. THE FOLLOWING PREVENTIVE ACTIONS HAVE TAKEN PLACE BY THE SUPPLIER WELMED INC: ADDED THE DISPOSAL METHOD OF THE PRODUCT DURING THE DEBUGGING PERIOD IN THE STANDARD OPERATING PROCEDURE. ALL PRODUCTS DURING THE DEBUGGING PERIOD ARE DISCARDED AS SCRAP. THE FIRST 10 MOLDS ARE SCRAPPED AFTER THE DEBUGGING IS QUALIFIED, AND THE 11TH MOLD WILL BE USED FOR THE FIRST ARTICLE INSPECTION. THE FOLLOWING CORRECTIVE ACTION HAVE TAKEN PLACE BY DEROYAL: THE SPONGE STICK WAS SET TO BE EVALUATED DURING THE INCOMING INSPECTION PROCESS. TWO SEPARATE LOT NUMBERS HAVE BEEN RECEIVED AND INSPECTED WITH NO ISSUES FOUND. THIS 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

    REPRESENTATIVE SAMPLES WERE RECEIVED FOR EVALUATION. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SPONGE STICK SUPPLIER (B)(4). THIS INVESTIGATION IS ONGOING AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SPONGE ON THE STICK FROM THE KIT CAME OFF WHEN INSIDE A PATIENT. THEY HAVE TO REMOVE IT FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594739 ST PREP KIT DRY LATEX SAFE 20C KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES, INC. 50-11068 55231818 00749756150149

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown