BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 22294029 · Received June 19, 2025

    Report

    Report Number
    9617594-2025-01293
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    May 13, 2025
    Report Date
    July 23, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619026059
    PMA / PMN Number
    K053106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR EVALUATION, BUT A LOT HISTORY REVIEW SHOULD BE PERFORMED.

    Additional Manufacturer Narrative · 0

    NO D1000 PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY REVIEW (DHR) WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A PROBABLE CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A TEGO CONNECTOR WHERE THE CUSTOMER REPORTED THAT FLUSHING WAS NOT POSSIBLE; THERE WERE NO PROBLEMS WHEN TEGO CONNECTORS WERE REMOVED. A MEDWATCH VOLUNTARY WITH MDR REPORT # MW5170834 WAS RECEIVED WHICH STATED "IT WAS REPORTED TO (B)(6) VIA FAX THAT ASPIRATION AND/OR FLUSHING WAS NOT POSSIBLE WHEN USING THE TEGO CONNECTORS. THERE WERE NO PROBLEMS WHEN TEGO CONNECTORS WERE REMOVED. " THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)". ADDITIONAL EVENT INFORMATION OBTAINED FROM UFMW: THE DATE OF THIS REPORT WAS 21-MAY-2025. THE COMMON DEVICE NAME IS SET, ADMINISTRATION, INTRAVASCULAR AND THE CATALOG # 09-1000-0. THE REPORT WAS NOT SENT TO FDA AND WAS NOT SENT TO MANUFACTURER. THE TYPE OF EVENT IS MALFUNCTION. SUMMARY REPORT AND NUMBER OF EVENTS IS 1. THE HEALTH EFFECT - CLINICAL CODE IS 4580: INSUFFICIENT INFORMATION. THE MEDICAL DEVICE PROBLEM CODE IS 1251: DIFFICULT TO FLUSH. UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT. CLIPORGO (B)(6) 2025 UPDATE: GCM RECEIVED A MEDWATCH VOLUNTARY WITH MDR REPORT # MW5170839 ON 06-JUN-2025, WHICH STATED "PLEASE NOTE THE ATTACHED COMPLAINT INVOLVES A DEVICE ASSOCIATED WITH AN ADVERSE EVENT THAT IS NOT MANUFACTURED BY (B)(6). IT WAS REPORTED TO (B)(6) VIA FAX THAT ASPIRATION AND/OR FLUSHING WAS NOT POSSIBLE WHEN USING THE TEGO CONNECTORS. THERE WERE NO PROBLEMS WHEN TEGO CONNECTORS WERE REMOVED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B) (2)." THE MODEL # IS 09-1000-0. THE HEALTH EFFECT - CLINICAL CODE IS 4582: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. THE MEDICAL DEVICE PROBLEM CODE IS 1252: FLUSHING PROBLEM. CLIPORGO (B)(6) 2025. UPDATE: GCM RECEIVED AN EMAIL ON 10-JUN-2025 FROM (B)(6) PROVIDING ADDITIONAL INFORMATION. THE CUSTOMER STATED THAT THE TEGO ON VENOUS WAS ABLE TO DRAW BACK BUT WAS NOT ABLE TO FLUSH THEN THEY REMOVED THE TEGO AND WAS ABLE TO FLUSH. ALSO, THE ARTERIAL TEGO WAS NOT ABLE TO FLUSH AND CHANGED OUT. THE EVENT DATE WAS ON 13-MAY-2025 AND 14-MAY-2025. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT. CLIPORGO (B)(6)2025 UPDATE: GCM RECEIVED AN EMAIL ON 11-JUN-2025 FROM (B)(6) PROVIDING ADDITIONAL INFORMATION: THE LIST NUMBER OF THE DEFECTIVE PRODUCT IS D1000 WITH LOT NUMBER 14289207. THE DEFECTIVE SAMPLE IS NOT AVAILABLE FOR EVALUATION OR RETURN BUT THE CUSTOMER STATED THAT THE PATIENT MAY HAVE ANOTHER TEGO WITH THE SAME LOT NUMBER. CLIPORGO (B)(6) 2025 THE EVENT INVOLVED A NEEDLE FREE HEMODIALYSIS TEGO CONNECTOR WHERE THE CUSTOMER REPORTED THAT ASPIRATION WAS NOT POSSIBLE WHEN USING THE TEGO CONNECTORS. A MEDWATCH VOLUNTARY WITH MDR REPORT # MW5170834 WAS RECEIVED STATING "IT WAS REPORTED TO (B)(6) VIA FAX THAT ASPIRATION AND/OR FLUSHING WAS NOT POSSIBLE WHEN USING THE TEGO CONNECTORS. THERE WERE NO PROBLEMS WHEN TEGO CONNECTORS WERE REMOVED. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)". AN ADDITIONAL MEDWATCH VOLUNTARY WITH MDR REPORT # MW5170839 WAS RECEIVED STATING "PLEASE NOTE THE ATTACHED COMPLAINT INVOLVES A DEVICE ASSOCIATED WITH AN ADVERSE EVENT THAT IS NOT MANUFACTURED BY (B)(6). IT WAS REPORTED TO (B)(6) VIA FAX THAT ASPIRATION AND/OR FLUSHING WAS NOT POSSIBLE WHEN USING THE TEGO CONNECTORS. THERE WERE NO PROBLEMS WHEN TEGO CONNECTORS WERE REMOVED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B) (2)." ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER STATING THAT THE TEGO ON ARTERIAL WOULD NOT WITHDRAW HEPARIN; THE TEGO WAS REMOVED AND IT WORKED. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863970 TEGO CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14289207 00840619026059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown