BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795

    MDR report key: 8613967 · Received May 15, 2019

    Report

    Report Number
    1625685-2019-00034
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    April 23, 2019
    Report Date
    June 18, 2019
    Manufacturer
    CAREFUSION, INC
    Product Code
    CAZ
    UDI-DI
    00382904058289
    PMA / PMN Number
    DISCRETION
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE WAS RECEIVED FOR EVALUATION. SAMPLE EVALUATION CONFIRMED THE REPORTED FAILURE MODE (BROKEN CATHETER). HOWEVER, THE EVALUATION OF THE COMPLAINT SAMPLE WAS NOT ABLE TO IDENTIFY ANY POTENTIAL CONTRIBUTOR TO THE OBSERVED DEFECT. THE COMPLAINT INVESTIGATION WAS ABLE TO CONFIRM THE REPORTED FAILURE MODE; HOWEVER, NO CONTRIBUTING FACTORS WERE ABLE TO BE IDENTIFIED AS PART NUMBER 8363807 IS A SUPPLIED PART. CONSEQUENTLY, A PROBABLE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MANNFORD MANUFACTURING FACILITY BASED ON THE INVESTIGATION RESULTS. SINCE THE INVESTIGATION WAS NOT ABLE TO IDENTIFY A PROBABLE ROOT CAUSE BASED ON THE COMPLAINT RESULTS, NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. HOWEVER, A SUPPLIER QUALITY NOTIFICATION WILL BE ISSUED TO EPIMED AND FUTURE OCCURRENCES WILL BE TRACKED AND TRENDING WILL BE PERFORMED AS A PART OF OUR QDA SYSTEM. A COMPLAINT HISTORY CHECK WAS NOT PERFORMED AS THE LOT NUMBER IS "UNKNOWN" FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BREAKAGE OCCURRED WITH A TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "EPIDURAL CATHETER BROKE"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BREAKAGE OCCURRED WITH A TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "EPIDURAL CATHETER BROKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403906 TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795 ANESTHESIA CONDUCTION KIT CAZ CAREFUSION, INC UNKNOWN 00382904058289

    Patients

    Seq Age Sex Outcome Treatment
    1 Other