BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER

    MDR report key: 19032148 · Received April 3, 2024

    Report

    Report Number
    9617594-2024-00361
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 3, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WAS RETURNED FROM THE CUSTOMER FOR COMPLAINT INVESTIGATION: ONE USED LIST #B1115, 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER; LOT #UNKNOWN. AS RECEIVED, AN UNKNOWN RESIDUAL WAS OBSERVED INSIDE THE SET. THE TUBE WAS SEPARATED FROM THE OUTLET FILTER PORT. THERE WAS NO SOLVENT IN THE TUBE OR THE FILTER PORT (ONLY SOLVENT RESIDUAL) OBSERVED THROUGH ULTRAVIOLET LIGHT. NO ADDITIONAL DAMAGE OR ANOMALIES WERE OBSERVED. THE ID OF THE TUBE WAS FOUND TO BE WITHIN SPECIFICATION. THE COMPLAINT OF DISCONNECTION CAN BE CONFIRMED BASED ON THE PHYSICAL SAMPLE EVALUATION. THE PROBABLE CAUSE WAS DUE TO INSUFFICIENT SOLVENT APPLIED DURING MANUAL ASSEMBLY PROCESS OF MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER. THE EXTENSION SET REPORTEDLY FELL OFF THE FILTER DURING USE. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO HUMAN HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689337 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown