BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 11826566 · Received May 14, 2021

    Report

    Report Number
    3000219639-2021-00009
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 14, 2021
    Manufacturer
    SLATER 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

    SEE THE INVESTIGATION REPORT AND CUSTOMER FOLLOW UP EMAIL FROM WELL LEAD, ATTACHED WITHIN THE ACTIVITY LOG. 1. AFTER RECEIVED THE COMPLAINT, WE DO AN INVESTIGATION ACCORDINGLY. NO NONCONFORMITY WAS FOUND WHEN REVIEW THE DHR AND RETAINED SAMPLES 2. FROM THE COMPLAINT DESCRIPTION AND PICTURES, WE CAN FIND THE FOREIGN MATTER ON CUFF. IN THE MANUFACTURE PROCESS, A 100% INSPECTION WAS CONDUCTED ON THE CUFF , THIS DEFECT CAN BE FOUND BY VISUAL INSPECTION AND PICKED OUT. 3. WE REVIEWED THE COMPLAINTS HISTORY OF THE PRODUCT AND NO SIMILAR FEEDBACK WAS FOUND. 4. IN THE MANUFACTURE PROCESS, CUFF IS MADE OF PVC MATERIAL BY BLOW MOLDING PROCESS DUE TO CHARACTERISTICS OF TECHNICAL PROCESS , THERE MAY BE INDIVIDUAL DEFECTIVE CUFF SIMILAR TO THE COMPLAINT SAMPLE. THESE DEFECTIVE CUFF WILL BE PICKED OUT AND SCRAPPED IN THIS CASE, QUALITY INSPECTION PERSONNEL MAY NOT FIND AND PICK OUT THIS DEFECTIVE PRODUCT IN TIME, RESULTING IN IT MIXING OF NORMAL PRODUCTS THE COMPLAINT INFORMATION HAS BEEN FEEDBACK TO RELATED PERSONNEL FOR AWARENESS. WE WILL CLOSELY MONITOR THE TRENDING FOR THE SIMILAR COMPLAINTS AND TAKE ACTIONS WHEN NECESSARY. RA: THIS FAILURE MODE (R8), IDENTIFIED ON THE RISK ANALYSIS FILE (RA-47), IS CONSIDERED A MAJOR (6) RISK AND DOES NOT MEET THE RISK THRESHOLD FOR CARB REVIEW.

    Description of Event or Problem · 0

    SIX DAYS AFTER THE HEART SURGERY, THE VENTILATOR ALARM SOUNDED AND THE NURSE CHECKED AND FOUND THAT THE CUFF WAS NOT FILLED WITH AIR. WHEN S/HE TRIED TO INFLATE THE CUFF AGAIN, THE INFLATION LINE CAME OFF.

    Additional Manufacturer Narrative · 1

    THE DEVICE FAILED WHILE IN PATIENT USE WHICH WOULD CAUSE A DELAY IN TREATMENT AND THE PATIENT TO BE RE-INTUBATED. 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 THE REPORTED INFORMATION, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

    Description of Event or Problem · 1

    SIX DAYS AFTER THE HEART SURGERY, THE VENTILATOR ALARM SOUNDED AND THE NURSE CHECKED AND FOUND THAT THE CUFF WAS NOT FILLED WITH AIR. WHEN S/HE TRIED TO INFLATE THE CUFF AGAIN, THE INFLATION LINE CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725924 SALTER LABS ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 8.0MM, , BTR SLATER LABS H-PFHV_80 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other