MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO¿ CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	D1000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred regarding a tego connector where the reporter reported that, "during the beginning of a dialysis session, and in some cases during the ending of the dialysis session, a leakage (backflow) from the tego valves was observed.They changed the tego valves of the customer with new ones, but the problem persisted.The date of the event was on (b)(6) 2026 until(b)(6) 2026, and from (b)(6) 2026 until (b)(6) 2026.This was identified in five (5) different cases (patients).No easily identifiable cuts or holes or other imperfections were noticed on the product.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and (b)(6) 2026 has been used as a placeholder.Investigation summary: received five (5) new.List #d1000, tego¿ connector; lot #14435490.No visual damages or anomalies were observed.The reported complaint of backflow could be confirmed from a lot history review.The returned samples were tested, and backflow could not be replicated.However, a lot history review shows the sample falls under the capa-0009146.The probable cause is from uneven application of adhesive during assembly in assembly plant.Lot history review: a lot history review shows the sample falls under capa-0009146.Corrective and preventative actions are in process.

• Brand Name: TEGO¿ CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25229656
• Report Number: 9617594-2026-00481
• Device Sequence Number: 13321465
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)300601(10)14435490
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K053106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D1000
• Device Lot Number: 14435490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1111-2026
• Patient Sequence Number: 1
• Patient Sex: Unknown