BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 16919645 · Received May 12, 2023

    Report

    Report Number
    3000219639-2023-00015
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    April 13, 2023
    Report Date
    April 12, 2023
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    UDI-DI
    00607411915871
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS AN INTERRUPTION OF THERAPY THAT COULD LEAD TO HYPOXIA. COMPLAINT HISTORY REVIEWED. THERE HAVE BEEN NO SIMILAR COMPLAINTS FOR 1600HF-25 CANNULA IN THE PREVIOUS 24 MONTHS. MORE INFORMATION SENT VIA TEXT MESSAGE AND PHONE CALL FROM CUSTOMER. CUSTOMER RECEIVES PRODUCT FROM MEDICAL SUPPLIER AS WELL AS PURCHASING FROM AMAZON. LOT# 354817 WAS BENT/KINKED IN PACKAGE. PURCHASED FROM AMAZON. SUNMED DOES NOT USE AMAZON AS A DISTRIBUTOR AND CANNOT CONTROL THE QUALITY OF PRODUCT DURING TRANSIT. MOST LIKELY ROOT CAUSE OF DEFECTS IS PRODUCT MISHANDLING DURING TRANSIT. RISK(RMA-20017A): R97: LOW OXYGEN DELIVERY - CANNULA MATERIAL DETERIORATES RESULTING IN LEAKS PRIOR TO FIRST USE - S=6 O=1 RPN=6. RPN < 25. R100: LOW OXYGEN DELIVERY - CANNULA TUBING DETERIORATES RESULTING IN TUBING COLLAPSE PRIOR TO FIRST USE - S=8 O=1 RPN=8. RPN < 25, THEREFORE RISK IS ACCEPTABLE. PRODUCT WAS PURCHASED THROUGH AN UNAPPROVED DISTRIBUTOR (AMAZON), ISSUE WILL NOT BE BROUGHT TO CARB.

    Additional Manufacturer Narrative · 0

    THERE WAS AN INTERRUPTION OF THERAPY THAT COULD LEAD TO HYPOXIA.

    Description of Event or Problem · 0

    KINKING IS PREVENTING FLOW OF OXYGEN. PATIENT CLAIMS THIS IS A LIFE THREATENING ISSUE AS THEY ARE NOT ABLE TO GET ADEQUATE OXYGEN.

    Description of Event or Problem · 0

    KINKING IS PREVENTING FLOW OF OXYGEN. PATIENT CLAIMS THIS IS A LIFE THREATENING ISSUE AS THEY ARE NOT ABLE TO GET ADEQUATE OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662587 SALTER LABS ADULT NASAL CANNULA WITH 25', 3- CHANNEL TUBE CAT SALTER LABS 16SOFT-HF-25 UNKNOWN 00607411915871

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other