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 Codes	Complete Blockage (1094); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On an unspecified date, a tego® connector was reportedly unable to aspirate through the device that was in use with patients in the training room for home hemodialysis training.They had to remove the tego's to aspirate blood from the central venous catheter (cvc) limbs, most of the time due to a long stringy blood clot but sometimes that wasn't the case.They are having to change out the tegos approximately 3x week due to this issue.They have started to instill heparin in the dwells, so they will see if that helps.There was patient involvement with no harm.This emdr reflects 2 similar occurrences/events.
Additional Manufacturer Narrative
Although multiple attempts were made to obtain the device, it is not available for investigation at this time.A review of the device history record is pending.

• 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: 25323078
• Report Number: 9617594-2026-00504
• Device Sequence Number: 12104492
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)310101(10)14841503
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2026

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: 14841503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTRAL VENOUS CATHETER (CVC), MFR UNK
• Patient Sex: Unknown