BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H/S CATHETER 5FR STYLET

    MDR report key: 8658373 · Received May 31, 2019

    Report

    Report Number
    1216677-2019-00096
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 7, 2019
    Report Date
    December 15, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    PMA / PMN Number
    K961752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE: (B)(4). INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION. X-NO SAMPLE RETURNED. X-REVIEW DHR. ANALYSIS AND FINDINGS: DISTRIBUTION HISTORY: THE COMPLAINT (B)(4) WAS MANUFACTURED AT CSI ON 10/16/18 UNDER WORK ORDER 253822. MANUFACTURING RECORD REVIEW: THE DHR FOR THIS UNIT WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD: SERVICE HISTORY RECORD NOT APPLICABLE TO THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE PRODUCT TWO-YEAR HISTORY INDICATED DID NOT REVEAL ANY TRENDS RELATED TO THE DESCRIPTION OF THE REPORTED EVENT. THE REPORTED EVENT WILL BE MONITORED FOR POSSIBLE FUTURE REPORTED EVENT TRENDING. PRODUCT RECEIPT: THE SAMPLE WAS NOT RETURNED AT THE TIME OF THIS INVESTIGATION, AND NO RMA WAS GIVEN. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT (B)(4) COULD NOT BE COMPLETED AS THE COMPLAINT (B)(4) HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE (B)(4) SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT (B)(4) COULD NOT BE COMPLETED AS THE COMPLAINT (B)(4) HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE (B)(4) SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME. THE PROCESS WAS REVIEWED AND EVALUATED, THERE WERE NO CHANGES AND NOTED THAT THE PRODUCTION LINE WAS STABLE OPERATING IN AN ACCEPTABLE MANNER. LOT STOCK WAS DEPLETED AND FURTHER EVALUATION WAS NOT POSSIBLE. CORRECTION AND/OR CORRECTIVE ACTION: COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. SEE ATTACHED COPIES OF TESTING REPORTS. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    PER EMAIL REPORT: " INCIDENCE 3: TESTED THE BALLOON BEFORE PROCEDURE, INJECTED SALINE FROM 3ML SYRINGE INTO BALLOON, THEN TRIED TO DEFLATE THE BALLOON, IT FAILED TO DEFLATE AT ALL." (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    PER EMAIL REPORT: " INCIDENCE 3: TESTED THE BALLOON BEFORE PROCEDURE, INJECTED SALINE FROM 3 ML SYRINGE INTO BALLOON, THEN TRIED TO DEFLATE THE BALLOON, IT FAILED TO DEFLATE AT ALL." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451079 H/S CATHETER 5FR STYLET H/S CATHETER 5FR STYLET LKF COOPERSURGICAL, INC. 61-3005 253822

    Patients

    Seq Age Sex Outcome Treatment
    1 Other