BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDI CATHETER ENFIT 6FR/49 CM, 5PCS

    MDR report key: 18137897 · Received November 15, 2023

    Report

    Report Number
    8010042-2023-02218
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    September 8, 2023
    Report Date
    November 15, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    UDI-DI
    17325710004606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN EDI CATHETER, SPECIFIED FOR A MAXIMUM USAGE PERIOD OF FIVE DAYS, WAS UTILIZED FOR 24 DAYS. UPON REMOVAL, THE MEASURED TOTAL LENGTH WAS 52 CM, DEVIATING FROM THE SPECIFIED LENGTH OF 49 CM. THE EDI CATHETER WAS REMOVED DUE TO CLOGGING AFTER FEEDING AND SUBSEQUENTLY RETURNED FOR INVESTIGATION. DESPITE THE NOTED DEFORMATION, IT WAS DETERMINED THAT THE NAVA TREATMENT WAS NOT AFFECTED. THE EDI SIGNAL, BEING DYNAMIC AND RESPONSIVE TO PHYSIOLOGICAL AND ENVIRONMENTAL FACTORS, REMAINED FUNCTIONAL DURING THE EDI CATHETER¿S USE. PHYSICAL MEASUREMENTS FOUND THE EDI CATHETER LENGTH MEASURED AT 520 MM, EXCEEDING THE SPECIFICATION OF 490 ± 5 MM. THE POSITION OF THE HUB WAS AT 440 MM, EXCEEDING THE SPECIFICATION OF 420 ± 5 MM. THE POSITIONS OF THE FIRST AND NINTH ELECTRODE RINGS WERE WITHIN SPECIFICATION, BUT THE REFERENCE ELECTRODE POSITION WAS OUT OF SPECIFICATION. VISUAL OBSERVATIONS NOTED A DISCOLORATION AT THE TIP OF THE EDI CATHETER, WHICH COULD INDICATE CHEMICAL DEGRADATION, LIKELY CAUSED BY PROLONGED EXPOSURE TO STOMACH ACID. THE ELECTRODE RINGS WERE INTACT AND NOT BROKEN. ACCORDING TO MANUFACTURING RECORDS, ALL MATERIAL PARAMETERS WERE WITHIN SPECIFIED LIMITS. THE EDI CATHETER MET ALL FINAL RELEASE CRITERIA AND THERE WERE NO IDENTIFIED NON-CONFORMITIES WITHIN THE BATCH. IN CONCLUSION, THE INVESTIGATION CONCLUDED THAT THE EDI CATHETER MET ALL MANUFACTURING SPECIFICATIONS AND RELEASE CRITERIA. THE PROLONGATION OF THE EDI CATHETER NOTED UPON EXTRACTION IS MOST LIKELY THE RESULT OF THE EXTENDED USAGE BEYOND THE RECOMMENDED DURATION OF FIVE DAYS, LEADING TO PROLONGED EXPOSURE TO CHEMICAL AND BIOLOGICAL ELEMENTS IN THE STOMACH ENVIRONMENT. A CORRECTION OF FIELD # D1 ¿ BRAND NAME, # D4 ¿ VERSION OR MODEL #, # D4 - UNIQUE IDENTIFIER (UDI) # AND # H4 - MANUFACTURE DATE WERE REQUIRED. D1 ¿ BRAND NAME ¿ PREVIOUS BRAND NAME: ENFIT EDI CATHETER. CORRECTED BRAND NAME: EDI CATHETER ENFIT 6FR/49 CM, 5PCS D4 ¿ VERSION OR MODEL # - PREVIOUS VERSION OR MODEL #: ENFIT 6FR/49 CM. CORRECTED VERSION OR MODEL #: 6883898 D4 - UNIQUE IDENTIFIER (UDI) # - PREVIOUS UNIQUE IDENTIFIER (UDI) #: MISSING. CORRECTED UNIQUE IDENTIFIER (UDI) #: (B)(6). H4 - MANUFACTURE DATE ¿ PREVIOUS MANUFACTURE DATE: MISSING. CORRECTED MANUFACTURE DATE: 05/13/2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER REMOVAL OF THE EDI CATHETER, THE USER MEASURED THE LENGTH AND FOUND THAT THE TOTAL LENGTH WAS 52 CM INSTEAD OF SPECIFIED 49 CM. THERE WAS NO PATIENT HARM. MANUFACTURER¿S REF #: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322643 EDI CATHETER ENFIT 6FR/49 CM, 5PCS GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB 6883898 3000314480 17325710004606

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown