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	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The event occurred on an unspecified date in february 2026 and involved a tego¿ connector.It is unclear if the central venous access device (cvad) was clamped at the time of the incident.The customer stated that the septum appeared to be domed/protruding outward.The event occurred during patient use when a new tego was changed prior to commencement of hemodialysis (hd).The set was replaced and therapy resumed without any problem.There was no iv solution or medication used.There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
D9 - date returned to mfr 20mar2026 investigation summary received one (1) used.List #d1000, tego® connector; lot #14414223.The seal was observed to be domed.The reported complaint of a protruding seal could be confirmed.The returned sample was observed to have a domed seal upon arrival.The probable cause is from uneven adhesive application during assembly in ensenada.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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: 24611326
• Report Number: 9617594-2026-00280
• Device Sequence Number: 9586031
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)300201(10)14414223
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: 14414223
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown