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	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An event involved a tego connector; reported that air was detected 2 hours into the run.Air was seen from the tego or catheter lumen along the arterial dialysis line.There was patient involvement, but unknown delay in therapy and no death or serious deterioration of a person.
Additional Manufacturer Narrative
The device is available for evaluation; however, has not been received.D4: only di provided as lot number is unknown.
Additional Manufacturer Narrative
Investigation summary: received one (1) used.List #d1000, tego® connector; lot #unknown.No visual damages or anomalies were observed.The reported complaint of air in line could be confirmed.The returned sample was tested and a leak was observed.The sample was disassembled and no damages were found on the seal or the body.The probable cause is unknown.A device history review could not be conducted because no lot number(s) was/were identified.

• 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: 24467933
• Report Number: 9617594-2026-00204
• Device Sequence Number: 10277437
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: 00840619026059
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown