BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED EXTENSION TUBING

    MDR report key: 21936244 · Received April 30, 2025

    Report

    Report Number
    9617594-2025-00866
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    March 19, 2025
    Report Date
    June 24, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K173477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED. LIST #UNKNOWN, EXTENSION SET W/ MICROCLAVE, AS RECEIVED, NO PHYSICAL DAMAGE OR OTHER ANOMALIES OBSERVED. THE SET WAS LEAK TESTED AS PER PS00-00003 P-1G-079- EXTENSION SET W/ MICROCLAVE; AS RECEIVED, NO AIR WAS DETECTED, FLOW WAS OCCLUDED FROM DRIED RESIDUALS AS RECEIVED. UNABLE TO CONFIRM CUSTOMER COMPLAINT OF AIR BUBBLE.

    Additional Manufacturer Narrative · 0

    A2 - DATE OF BIRTH - THE PATIENTS AGE WAS LISTED AS 0 DAYS ON THE INITIAL REPORT (B)(6). D4 AND H4 THE LOT#, EXPIRATION DATE, AND MANUFACTURE DATE ARE UNKNOWN. BECAUSE ICU MEDICAL HAS MULTIPLE MANUFACTURING LOCATION IS ALSO UNKNOWN. ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. WAS ENTERED AS A PLACE HOLDER. THE INVESTIGATION IS PENDING COMPLETION. UPON COMPLETION, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED REGARDING AN UNSPECIFIED EXTENSION TUBING THAT EXPERIENCED AIR IN LINE. THE REPORT STATED THAT WHEN SYRINGE MEDICATION WAS COMPLETE, AIR BUBBLE FOUND IN MICROBORE TUBING AND UNABLE TO PUT FLUSH BEHIND THE TUBING BECAUSE DID NOT WANT TO INFUSE THE AIR BUBBLE FROM TUBING. THE AFFECTED AREA/UNIT LOCATION WAS AT THE INFUSION CLINIC. THE PATIENT WAS MALE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241335 UNSPECIFIED EXTENSION TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male