BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20000805 · Received August 20, 2024

    Report

    Report Number
    9617594-2024-01160
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    July 14, 2024
    Report Date
    November 1, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619045524
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR EVALUATION. THE DEVICE HAS BEEN REQUESTED TO BE RETURNED, HOWEVER, IT HAS NOT BEEN RECEIVED. WITHOUT THE RETURNED DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 0

    ONE (1) USED SAMPLE LIST #B1115, 12" WAS RETURNED FOR EVALUATION. AS RETURNED THE TUBE FROM THE INLET FILTER PORT WAS OBSERVED TO BE SEPARATED FROM THE FILTER. BOTH COMPONENTS WERE OBSERVED THROUGH ULTRAVIOLET (UV) LIGHT AND NO SOLVENT MARKS WERE OBSERVED. THE OPTICAL DENSITY (OD) OF THE SEPARATED TUBE WAS MEASURED FINDING IT WITHIN SPECIFICATION. COMPLAINTS OF SEPARATION CAN BE CONFIRMED BASED ON THE PHYSICAL SAMPLE EVALUATION. THE PROBABLE CAUSE IS DUE TO AN INSUFFICIENT SOLVENT APPLIED DURING MANUAL PROCESS ASSEMBLY IN ENSENADA. A DEVICE HISTORY REVIEW (DHR) LOT # REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED. D9 - DEVICE AVAILABLE FOR EVALUATION: YES; D9 - DATE RETURNED TO MFG: 9/18/2024.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION B3, B5 AND D9.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER. THE CUSTOMER REPORTED THAT THE NURSE NOTICED A SOILED BLANKET AND UPON FURTHER INVESTIGATION, THE TUBING CONNECTED TO THE ACTUAL FILTER WAS NOT INTACT (WAS DISCONNECTED). THE CUSTOMER STATED THAT THE ISSUE WAS IDENTIFIED WITH SUPPLY ITEM. THE NURSING DEPARTMENT WAS AFFECTED BY THE ISSUE. THE CUSTOMER STATED THAT A MIDAS INCIDENT REPORT WAS CREATED AND ASSIGNED THE MIDAS CASE NUMBER (B)(4). THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM/ADVERSE EVENT, AND UNKNOWN DELAY OF THERAPY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT HERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210146 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 00840619045524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown