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	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Additional used device has been received for the investigation and a reported incident involving a tego connector was associated with blockages and leaks.No patient harm or injuries were reported as a result of the event, and there was no delay in therapy.
Additional Manufacturer Narrative
One used device was returned for investigation.The device was visually inspected and observed to have torn seal.The complaint could be confirmed.The probable root cause of the reported issue is uneven adhesive application during assembly.Lot history was reviewed and no anomalies were noted.

• 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50524488
• Report Number: 9617594-2026-01139
• Device Sequence Number: 18682872
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)300201(10)14321159
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2026

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: 14321159
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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