BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER 040F, STERILE

    MDR report key: 24988303 · Received April 24, 2026

    Report

    Report Number
    1417592-2026-00558
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 24, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    BTT
    PMA / PMN Number
    K141353
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE REPORT, "THERE IS A CRACK ON THE DEVICE AT ONE OF THE SMALL NOTCHES. I TOOK A PHOTO, BUT IT'S DIFFICULT TO SEE CLEARLY. ONLY ONE DEVICE IS AFFECTED SO FAR, I DON'T HAVE THE PRECISE BATCH NUMBER, BUT IT WAS IN THE BAG WITH THE HUMIDIFIER, BATCH 25B542, DATED 08/10/2029. IT APPEARS THAT THIS CRACK APPEARS DURING HANDLING BY HEALTHCARE STAFF AND CAUSES A LEAK. THE PERSON CLAIMS TO HAVE FOLLOWED THE CORRECT HANDLING INSTRUCTIONS. THE AFFECTED DEVICE IS AT THE PHARMACY." THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PER THE REPORT, "THERE IS A CRACK ON THE DEVICE AT ONE OF THE SMALL NOTCHES. I TOOK A PHOTO, BUT IT'S DIFFICULT TO SEE CLEARLY. ONLY ONE DEVICE IS AFFECTED SO FAR, I DON'T HAVE THE PRECISE BATCH NUMBER, BUT IT WAS IN THE BAG WITH THE HUMIDIFIER, BATCH 25B542, DATED 08/10/2029. IT APPEARS THAT THIS CRACK APPEARS DURING HANDLING BY HEALTHCARE STAFF AND CAUSES A LEAK. THE PERSON CLAIMS TO HAVE FOLLOWED THE CORRECT HANDLING INSTRUCTIONS. THE AFFECTED DEVICE IS AT THE PHARMACY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586104 ADAPTER 040F, STERILE ADAPTER 040F, STERILE BTT MEDLINE INDUSTRIES, LP 14D25

    Patients

    Seq Age Sex Outcome Treatment
    1