BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 11987373 · Received June 11, 2021

    Report

    Report Number
    3000219639-2021-00013
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 24, 2021
    Report Date
    June 3, 2021
    Manufacturer
    SALTER LABS
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HISTORY FOR THIS PART NUMBER WAS REVIEWED FOR THE LAST 24 MONTHS. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED AND THIS ISSUE DOES NOT APPEAR TO BE TRENDING, BUT WILL CONTINUE TO BE MONITORED. WELL LEAD IS PERFORMING THE FORMAL INVESTIGATION OF THIS COMPLAINT AND HANDLING ALL CUSTOMER FOLLOW UP CORRESPONDENCE. PLEASE SEE THE ATTACHED INVESTIGATION REPORT. RA: THIS IS AN ISOLATED INCIDENT AND DOES NOT REQUIRE THE CAPA PROCESS, BUT WILL CONTINUE TO BE MONITORED. THIS FAILURE MODE IS NOT IDENTIFIED ON THE RISK ANALYSIS FILE AND NEEDS TO BE ADDED. (B)(4) FROM REGULATORY WAS NOTIFIED ON 7/15/2021.

    Description of Event or Problem · 0

    ACCORDING TO A REPORT FROM THE HOSPITAL, THE CUFF DID NOT INFLATE DURING USE, EVEN THOUGH THERE WERE NO ABNORMALITIES DURING THE CUFF CHECK. UPON CHECKING THE RETURNED ITEM, WE CONFIRMED THAT THE CUFF WAS GLUED TO THE TUBE AND THAT THE CUFF WAS UNEVENLY INFLATED.

    Additional Manufacturer Narrative · 1

    THE FAILURE TO INFLATE THE CUFF HAPPENED DURING 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. BASED ON THIS INFORMATION THIS IS A REPORTABLE EVENT.

    Description of Event or Problem · 1

    ACCORDING TO A REPORT FROM THE HOSPITAL, THE CUFF DID NOT INFLATE DURING USE, EVEN THOUGH THERE WERE NO ABNORMALITIES DURING THE CUFF CHECK. UPON CHECKING THE RETURNED ITEM, WE CONFIRMED THAT THE CUFF WAS GLUED TO THE TUBE AND THAT THE CUFF WAS UNEVENLY INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885038 SALTER LABS ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 8.0MM, , BTR SALTER LABS I-PFHV-65 2006HV1017J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other