BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 11756450 · Received April 30, 2021

    Report

    Report Number
    3000219639-2021-00008
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 15, 2021
    Manufacturer
    SALTER LABS
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT RETURNED PRODUCT FOR A FORMAL INVESTIGATION. COMPLAINT HISTORY FOR THIS PART NUMBER WAS REVIEWED AND ONLY ONE SIMILAR COMPLAINT HAS BEEN REPORTED. THIS FAILURE MODE DOES NOT APPEAR TO BE TRENDING AT THIS TIME BUT WILL CONTINUE TO BE MONITORED. THE MOST LIKELY ROOT CAUSE OF THIS ISSUE IS THAT THE CUFF WAS DAMAGED DURING THE INTUBATION. CUSTOMER FOLLOW UP WAS PERFORMED VIA EMAIL, OFFERING THE MOST LIKELY ROOT CAUSE OF THIS ISSUE. SUPPLIER NOTIFICATION WAS ALSO CONDUCTED VIA EMAIL. THE FAILURE MODE (R25) CUFF LOSES PRESSURE CAUSING LOSS OF OR INADEQUATE VENTILATION IS IDENTIFIED ON THE RISK ANALYSIS FILE (RA-47) FOR ET TUBES. THE SEVERITY OF HARM FOR THIS FAILURE MODE IS A MAJOR (6) RISK AND DOES NOT MEET THE RISK THRESHOLD FOR CARB REVIEW.

    Description of Event or Problem · 0

    AFTER THE NASAL INTUBATION, ALL 4 TUBES USED SHOWED LEAKS AND DID NOT HOLD THE AIR - CRITICAL SITUATION FOR THE PATIENT, AS RE-INTUBATION WAS NECESSARY! THE DEFECTIVE TUBE SENT IN HAS 2 SMALL HOLES IN THE CUFF.

    Additional Manufacturer Narrative · 1

    NASAL TUBES WERE UNDAMAGED/TIGHT BEFORE USE (CUFF CONTROL BY MEANS OF BLOCK SYRINGE). AFTER THE NASAL INTUBATION, ALL 4 TUBES USED SHOWED LEAKS AND DID NOT HOLD THE AIR. THE LEAK OCCURRED AFTER INTUBATION, WHICH MEANS THE ETT WOULD NEED TO BE REPLACED. THEY CANNOT LEAVE AN ENDOTRACHEAL TUBE IN PLACE IF THEY CANNOT KEEP THE CUFF INFLATED. THE INCIDENT WOULD REQUIRE AN INTERVENTION; A DEFLATED CUFF COULD CAUSE LOSS OF DELIVERED VOLUME. THE IFU INSTRUCTS USERS TO TEST FOR PROPER INFLATION OF THE CUFF PRIOR TO INTUBATION AND THIS COMMON PRACTICE IN AN INTUBATION PROCEDURE.

    Description of Event or Problem · 1

    AFTER THE NASAL INTUBATION, ALL 4 TUBES USED SHOWED LEAKS AND DID NOT HOLD THE AIR CRITICAL SITUATION FOR THE PATIENT, AS RE-INTUBATION WAS NECESSARY! THE DEFECTIVE TUBE SENT IN HAS 2 SMALL HOLES IN THE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654410 SALTER LABS ENDOTRACHEAL TUBE, PREFORMED NASAL, CUFFED (PFNC), PARKER, 7.0MM BTR SALTER LABS I-PFNC-70 1908NC1944K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other