BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 14173178 · Received April 21, 2022

    Report

    Report Number
    3000219639-2022-00020
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 21, 2022
    Manufacturer
    SALTER LABS
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE FAILED WHILE IN PATIENT USE WHICH WOULD CAUSE A DELAY IN TREATMENT AND THE PATIENT TO BE REINTUBATED. THEY CANNOT LEAVE AN ENDOTRACHEAL TUBE IN PLACE IF THEY CANNOT KEEP THE CUFF INFLATED. THE IFU INSTRUCTS USERS TO TEST FOR PROPER INFLATION OF THE CUFF PRIOR TO INTUBATION AND THIS COMMON PRACTICE IN AN INTUBATION PROCEDURE. BASED ON THIS INFORMATION THIS IS A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    THE DEVICE FAILED WHILE IN PATIENT USE WHICH WOULD CAUSE A DELAY IN TREATMENT AND THE PATIENT TO BE REINTUBATED. THEY CANNOT LEAVE AN ENDOTRACHEAL TUBE IN PLACE IF THEY CANNOT KEEP THE CUFF INFLATED. THE IFU INSTRUCTS USERS TO TEST FOR PROPER INFLATION OF THE CUFF PRIOR TO INTUBATION AND THIS COMMON PRACTICE IN AN INTUBATION PROCEDURE. BASED ON THIS INFORMATION THIS IS A REPORTABLE EVENT. COMPLAINT HISTORY FOR H-PFNC-XX REVIEWED. THERE HAVE BEEN NO COMPLAINTS FOR PREFORMED NASAL CUFFED ET TUBES IN THE PAST 24 MONTHS. COMPLAINT CANNOT BE CONFIRMED DUE TO NO RETURNED PRODUCT OR PICTURES OF COMPLAINT TAKEN. WITHOUT AN INVESTIGATION, ROOT CAUSE CANNOT BE DETERMINED. LIKELY ROOT CAUSE IS THAT THE CUFF WAS SCRATCHED ON HANDLING POST LEAK TEST. RISK (RA-47): R25: CUFF LOSES PRESSURE - 2. CUFF HAVING PIN HOLE- S=6 O=2 RPN=12. RPN<25 THEREFORE RISK IS ACCEPTABLE.

    Description of Event or Problem · 0

    WHEN INSERTING THE TUBE THE BALLOON IS RUPTURING, THE CUFF IS TEARING.

    Description of Event or Problem · 0

    WHEN INSERTING THE TUBE THE BALLOON IS RUPTURING, THE CUFF IS TEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089075 SALTER LABS ENDOTRACHEAL TUBE, PREFORMED NASAL, CUFFED (PFNC), PARKER, 7.0MM BTR SALTER LABS H-PFNC-70 2107NC1487K

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other