BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY,CATHETER,SUCTION,8 FR,2 GLV,MINI

    MDR report key: 18861549 · Received March 7, 2024

    Report

    Report Number
    1417592-2024-00342
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    February 8, 2024
    Report Date
    April 9, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OFR
    UDI-DI
    40080196033523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED H6- TYPE OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER ON 2/8/2024," AFTER SEVERAL ATTEMPTS TO CONNECT THE DEVICE WITHOUT SUCCESS, THEY HAD TO GET ANOTHER PIECE TO CONNECT THE TWO. THIS CAUSED A DELAY IN THE INTUBATION OF AN INFANT THAT URGENTLY NEEDED IT". THE CUSTOMER REPORTED THAT THE "STAFF HAD TO GO GET A CONNECTER PIECE FROM THE STOCKROOM TO MAKE THE CONNECTION". THE CUSTOMER REPORTED THAT THERE WAS NO INJURY BUT THAT THIS "DELAYED" THE PROCEDURE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. 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

    ACCORDING TO THE CUSTOMER ON 2/8/2024," AFTER SEVERAL ATTEMPTS TO CONNECT THE DEVICE WITHOUT SUCCESS, THEY HAD TO GET ANOTHER PIECE TO CONNECT THE TWO. THIS CAUSED A DELAY IN THE INTUBATION OF AN INFANT THAT URGENTLY NEEDED IT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170690 TRAY,CATHETER,SUCTION,8 FR,2 GLV,MINI OFR MEDLINE INDUSTRIES LP 6052305019 40080196033523

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other