BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 20402767 · Received October 8, 2024

    Report

    Report Number
    2134070-2024-00019
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 18, 2024
    Manufacturer
    STERILMED, INC.
    Product Code
    OWQ
    UDI-DI
    10888551045094
    PMA / PMN Number
    K161700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING PRE-OP FOR AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER FOR USE ON GE IMAGING SYSTEM AND THE INSIDE OF THE PACKAGING HAD DEBRIS WHICH WAS POSSIBLY BLOOD. THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION ON 6-NOV-2024. A NON-STERILE REPROCESSED SOUNDSTAR® ECO 8F G DIAGNOSTIC ULTRASOUND CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVED THE DEVICE A VISUAL INSPECTION WAS PERFORMED AND TWO (2) BENT CONDITIONS WERE FOUND ON THE SHAFT OF THE CATHETER, THE FIRST AT 26.4 CM AND THE SECOND AT 54 CM FROM THE STRAIN RELIEF. NO FOREIGN MATTER/RESIDUES WERE OBSERVED ON THE CATHETER. THE MARK ON THE DEVICE INDICATED HAD BEEN REPROCESSED ONE (1) TIME. THE DEVICE HISTORY RECORD FOR LOT 2208704 WAS REVIEWED AND THERE WERE NO IDENTIFIED MANUFACTURING DEFICIENCIES OR INTERNAL ACTIONS. THE ISSUE REGARDING TO DEBRIS OR BLOOD WAS NOT CONFIRMED AS NO FOREIGN MATTER/FOREIGN RESIDUES WERE FOUND ON THE CATHETER, AND NO FURTHER INVESTIGATION CAN BE PERFORMED WITHOUT THE ORIGINAL PACKAGING. THE BENT CONDITIONS WERE NOT ORIGINALLY REPORTED, AND THE EXACT TIME OF OCCURRENCE CANNOT BE DETERMINED; THEREFORE, THIS IS NOT CONSIDERED RELATED TO THE ISSUE REPORTED. THE INSTRUCTIONS FOR USE (IFU) INDICATES THE FOLLOWING: BEFORE USE, INSPECT THE PACKAGING. DO NOT USE IF OPEN OR DAMAGED. USING ASEPTIC TECHNIQUE, REMOVE THE CATHETER FROM ITS PACKAGE AND PLACE IT IN A STERILE WORKING AREA. INSPECT THE CATHETER CAREFULLY FOR ELECTRODE INTEGRITY AND OVERALL CONDITION. AS PART OF STERILMED'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS, INCLUDING CLEANING, RED INSPECTION, STERILIZATION, AND PACKAGE INSPECTION PRIOR TO SHIPPING DURING THE REPROCESSING PROCESS TO PREVENT CONTAMINATED DEVICES FROM LEAVING THE FACILITY. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. 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. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE-OP FOR AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER FOR USE ON GE IMAGING SYSTEM AND THE INSIDE OF THE PACKAGING HAD DEBRIS WHICH WAS POSSIBLY BLOOD. THE CATHETER BAG WAS OPENED BUT THE CATHETER WAS NOT REMOVED FROM THE PACKAGING. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52856 NA REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER OWQ STERILMED, INC. 2208704 10888551045094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown