BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM

    MDR report key: 16876248 · Received May 5, 2023

    Report

    Report Number
    2134070-2023-00015
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    March 28, 2023
    Report Date
    May 26, 2023
    Manufacturer
    STERILMED, INC.
    Product Code
    OWQ
    UDI-DI
    10888551004732
    PMA / PMN Number
    K043453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE STERILMED PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY STERILMED, INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, STERILMED, INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) PROCEDURE WITH A CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM. THE DEVICE HAD SUBSTANCE ON THE CATHETER INSIDE OF THE PACKAGING. THEY REPLACED THE CATHETER. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE PRIMARY PACKAGING BOX WAS OPENED BEFORE THE SURGERY. NO PHYSICAL DAMAGE OBSERVED. THERE WAS NO OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE (OUTER BOX, TRAY, POUCH). THE DEVICE EVALUATION WAS COMPLETED ON 25-MAY-2023. THE PRODUCT WAS RETURNED TO STERILMED FOR EVALUATION, RECEIVED IN A RESEALABLE, DECONTAMINATION BAG. NONE OF THE ORIGINAL PACKAGING WAS RETURNED. STERILMED PERFORMED VISUAL INSPECTION AND FUNCTIONAL TEST ON THE RETURNED DEVICE. FUNCTIONAL TESTING WAS CONDUCTED, IN ACCORDANCE WITH STERILMED¿S PROCEDURES. NO ISSUES OR ERRORS WERE OBSERVED. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THE DEVICE WAS RECEIVED IN GOOD CONDITION, WITH NO OBSERVED DAMAGE. THE SHAFT AND HANDLE WERE EXAMINED AND NO FOREIGN MATTER WAS OBSERVED ANYWHERE ON THE SURFACE AREA OF THE DEVICE. THE DESCRIBED EVENT COULD NOT BE CONFIRMED SINCE NO FOREIGN MATTER WAS DETECTED. AS PART OF STERILMED¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE DHR FOR LOT 2187045 WAS REVIEWED AND THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING PRIOR TO BEING DISTRIBUTED TO THE FIELD, AS THERE ARE INSPECTIONS AT CONTROL POINTS BASED ON THE PROCESS TO AVOID THIS TYPE OF CONDITION FROM LEAVING THE FACILITY. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED AND THERE ARE NO IDENTIFIED INTERNAL ACTIONS RELATED TO THE COMPLAINT FOUND DURING THE REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) PROCEDURE WITH A CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM AND FOREIGN MATTER INSIDE THE PACKAGING ISSUE OCCURRED. THE DEVICE HAD SUBSTANCE ON THE CATHETER INSIDE OF THE PACKAGING. THEY REPLACED THE CATHETER. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE PRIMARY PACKAGING BOX WAS OPENED BEFORE THE SURGERY. NO PHYSICAL DAMAGE OBSERVED. THERE WAS NO OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE (OUTER BOX, TRAY, POUCH). THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR THE FOREIGN MATTER INSIDE THE PACKAGING UNDER THE CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM (STERILMED DEVICE) ON 07-APR-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2211817 CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER OWQ STERILMED, INC. ACU10135936 2187045 10888551004732

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKNOWN BRAND CATHETER.