BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 GANG 1O2¿ MANIFOLD W/CHECK VALVE, ROTATING LUER, APPX 1.2ML

    MDR report key: 17886091 · Received October 6, 2023

    Report

    Report Number
    9617594-2023-00808
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    August 18, 2023
    Report Date
    September 12, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619070052
    PMA / PMN Number
    K974589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY REPORT (DHR) FOR LOT 5910205 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADVERSE EVENT PROBLEM - TYPE OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    E1 - INITIAL REPORTER ADDRESS 1: (B)(6). ADDITIONAL CONTACT: (B)(6). THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE A PROBABLE CAUSE IS UNABLE TO BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 3 GANG 1O2¿ MANIFOLD W/CHECK VALVE, ROTATING LUER, APPX 1.2ML WHERE A LEAK OCCURRED. THE CUSTOMER REPORTED THAT A PATIENT UNDERWENT HIP REPLACEMENT FOR INTERTROCHANTERIC FRACTURE OF FEMUR UNDER GENERAL ANESTHESIA. INTRAVENOUS FLUIDS WERE ROUTINELY ADMINISTERED, AND DISPOSABLE SMART VALVE WERE INSTALLED. THE PHENOMENON OF DRUG. LEAKAGE DURING ROUTINE INJECTION OF NARCOTIC DRUGS MAY LEAD TO INACCURATE DRUG DOSAGE AND THE TOTAL AMOUNT OF DRUG ADMINISTRATION CANNOT BE ACCURATELY JUDGED. THE REPORTER FURTHER MENTIONED STATED THE HARM TYPE IS SERIOUS INJURY. THE DESCRIPTION OF HARM IS LEAKAGE RESULTS IN INACCURATE DOSE CONTROL OF ANESTHETIC DRUGS, AFFECTS THE OPERATION PROCESS, AND POSES A HIGH RISK OF CLINICAL ASEPTIC OPERATION. THE EVENT HAPPENED IN A MEDICAL INSTITUTION TO A 37 Y.O/MALE FOR MULTI-CHANNEL DRUG DELIVERY. FURTHERMORE, THE EVENT SURVEILLANCE: LOCAL NMPA REVIEW RESULT: PASS BY LOCAL NMPA. NAME: (B)(6) MONITORING CENTER. EVENT EVALUATION AND MEASURES WERE TAKEN, CAUSE ANALYSIS: THE INTERFACE TIGHTNESS IS INSUFFICIENT. PRELIMINARY PROCESSING SITUATION: REPLACE THE PRODUCT. DESCRIPTION OF HARM WAS NO. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071345 3 GANG 1O2¿ MANIFOLD W/CHECK VALVE, ROTATING LUER, APPX 1.2ML SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5910205 00840619070052

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male DISPOSABLE SMART VALVE, MFR UNK.| INTRAVENOUS FLUIDS, MFR UNK.| UNSPECIFIED NARCOTIC DRUG, MFR UNK.