BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS TRAY

    MDR report key: 7990250 · Received October 22, 2018

    Report

    Report Number
    3005011024-2018-00006
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    September 24, 2018
    Report Date
    October 22, 2018
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    OEQ
    UDI-DI
    00749756640473
    PMA / PMN Number
    ENFORCEMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: IN ITS SCAR RESPONSE, (B)(4) STATED THAT EVERY BUNDLE OF SPONGES GOES THROUGH AN AUTOMATIC COUNTING MACHINE FOR PIECE COUNT VERIFICATION. IT IS POSSIBLE THE REPORTED INCIDENT IS THE RESULT OF A MANUFACTURING ERROR IN WHICH AN EMPLOYEE ACCIDENTALLY RETAINED THE WRONG PIECE COUNT BUNDLE INSTEAD OF REJECTING IT. CORRECTIVE ACTION: THE VENDOR REPORTED IN ITS SCAR THAT TRAINING ON THE PIECE COUNT MACHINE OPERATION PROCEDURE AND ADDITIONAL INSPECTIONS WILL BE PERFORMED. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT A CONVENIENCE KIT (PART 89-5525, LOT 47941027) CONTAINED A PACK OF LAP SPONGES WITH SEVEN PIECES INSTEAD OF FIVE. THE END USER REPORTED THIS INCIDENT TO THE FDA. THE DEFECTIVE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEROYAL COMPLAINT INVESTIGATOR REVIEWED THE WORK ORDER FOR POSSIBLE DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE BILL OF MATERIALS WAS REVIEWED AND IT WAS DETERMINED THE AFFECTED RAW MATERIAL COMPONENT WAS PART 5-1819, A LAP SPONGE PACK SUPPLIED TO DEROYAL BY (B)(4). THIS PACK COMES TO DEROYAL IN BULK IN BUNDLED STACKS OF FIVE. DEROYAL EMPLOYEES DO NOT UNBUNDLE THESE STACKS AT ANY POINT DURING THE KIT ASSEMBLY PROCESS. THEREFORE, THE REPORTED NON-CONFORMANCE WAS DETERMINED TO BE A VENDOR ISSUE. THE SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR THE YEARS 2016-2018 FOR SIMILAR ISSUES. PREVIOUS ISSUES SIMILAR TO THE REPORTED COMPLAINT WERE IDENTIFIED, AND A NEW SCAR WAS ISSUED TO (B)(4). A RESPONSE HAS BEEN RECEIVED AND ACCEPTED BY DEROYAL'S COMPLAINT INVESTIGATOR. DEROYAL WILL CONTINUE TO MONITOR POST-MARKET FEEDBACK AND WILL RECOGNIZE IN THE FUTURE IF THE ISSUE REOCCURS.

    Description of Event or Problem · 1

    THE CONVENIENCE KIT CONTAINED SEVEN SPONGES WHEN THERE ONLY SHOULD HAVE BEEN FIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833525 PERCUTANEOUS TRAY ANGIOGRAPHY/ANGIOPLASTY KIT OEQ DEROYAL INDUSTRIES, INC. 89-5525 47941027 00749756640473

    Patients

    Seq Age Sex Outcome Treatment
    1