BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC CATHETER TRAY

    MDR report key: 7561356 · Received June 1, 2018

    Report

    Report Number
    3005011024-2018-00002
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    May 7, 2018
    Report Date
    June 25, 2018
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    OEQ
    UDI-DI
    00749756248686
    PMA / PMN Number
    ENFORCEMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: THE TOWEL MANUFACTURER, GD MEDICAL, STATED IN ITS SUPPLIER CORRECTIVE ACTION REQUEST THAT IT DETERMINED THE ROOT CAUSE TO BE AN INADEQUATE INSPECTION PROCESS AND POOR ATTENTION TO DETAIL DURING MANUFACTURING. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, GD MEDICAL INDICATED APPLICABLE PERSONNEL WERE RE-TRAINED ON THE INSPECTION PROCESS TO ENSURE PRODUCT IS RELEASED WITHIN SPECIFICATION AND WITHOUT LOOSE THREADS. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (CALL 44134) WAS RECEIVED FOR A CARDIAC CATHETERIZATION TRAY (FINISHED GOOD 50-13119, LOT 46982046), WHICH INDICATED THERE WAS LINT AND LOOSE THREADS ON A TOWEL CONTAINED WITHIN THE TRAY. A SAMPLE WAS RETURNED TO DEROYAL FOR REVIEW. THE RETURNED SAMPLE DID CONTAIN LOOSE THREADS. THE INVESTIGATOR REVIEWED THE WORK ORDER FOR POSSIBLE DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO DISCREPANCIES WERE IDENTIFIED. THE BILL OF MATERIALS FOR THE FINISHED GOOD WAS REVIEWED, AND THE AFFECTED RAW MATERIAL WAS IDENTIFIED AS PART NUMBER 5-5338, A GREEN OPERATING ROOM TOWEL. LOT MAPPING SHOWS THAT THIS TOWEL IS SUPPLIED TO DEROYAL BY GD MEDICAL. A SUPPLIER NOTIFICATION LETTER WAS SENT TO GD MEDICAL TO NOTIFY THEM OF THE REPORTED EVENT. THE RETURNED SAMPLE ALSO WAS FORWARDED TO GD MEDICAL AND WAS RECEIVED MAY 16, 2018. A RESPONSE FROM GD MEDICAL WAS RECEIVED. PREVENTIVE ACTION: IN ITS SCAR RESPONSE, GD MEDICAL STATED IT IMPLEMENTED THE FOLLOWING PREVENTIVE ACTIONS: TIGHTENED INSPECTION, LINE CLEARANCE PROCESS, AND EMPLOYEE TRAINING. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    TOWELS CONTAINED IN A CARDIAC CATH TRAY ARE LINTING. RANDOM LOOSE STRANDS OF THREAD ARE FALLING OFF OF THE TOWELS. THE END USER IS CONCERNED THE LINT OR THREAD COULD END UP IN A HEART CATHETER.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED FOR A CARDIAC CATHETERIZATION TRAY (FINISHED GOOD 50-13119, LOT 46982046), WHICH INDICATED THERE WAS LINT AND LOOSE THREADS ON A TOWEL CONTAINED WITHIN THE TRAY. A SAMPLE WAS RETURNED TO DEROYAL FOR REVIEW. THE RETURNED SAMPLE DID CONTAIN LOOSE THREADS. THE INVESTIGATOR REVIEWED THE WORK ORDER FOR POSSIBLE DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO DISCREPANCIES WERE IDENTIFIED. THE BILL OF MATERIALS FOR THE FINISHED GOOD WAS REVIEWED, AND THE AFFECTED (B)(4) MATERIAL WAS IDENTIFIED AS PART NUMBER 5-5338, A GREEN OPERATING ROOM TOWEL. LOT MAPPING SHOWS THAT THIS TOWEL IS SUPPLIED TO DEROYAL BY (B)(4). A SUPPLIER NOTIFICATION LETTER WAS SENT TO (B)(4) TO NOTIFY THEM OF THE REPORTED EVENT. THE RETURNED SAMPLE ALSO WAS FORWARDED TO (B)(4) AND WAS RECEIVED MAY 16, 2018. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    TOWELS CONTAINED IN A CARDIAC CATH TRAY ARE LINTING. RANDOM LOOSE STRANDS OF THREAD ARE FALLING OFF OF THE TOWELS. THE END USER IS CONCERNED THE LINT OR THREAD COULD END UP IN A HEART CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404085 CARDIAC CATHETER TRAY ANGIOGRAPHY/ANGIOPLASTY KIT OEQ DEROYAL INDUSTRIES, INC. 50-13119 46982046 00749756248686

    Patients

    Seq Age Sex Outcome Treatment
    1