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	Tear, Rip or Hole in Device Packaging (2385); Air/Gas in Device (4062)
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
It is unknown if the device will be received for evaluation; a device history should be performed.
Event or Problem Description
The event occurred on an unspecified date and involved a tego¿ connector where the customer reported that as the plunger was pulled back, the entire syringe released from the end of the connector cap, and air began to be sucked into the exposed lumen.The clamp was immediately closed.Upon inspection, the customer stated that the rubberized coating on the tego connector cap had torn and the seal inside the end of the cap pulled out resulting in the syringe sliding off and air exposure.The home hemodialysis (hhd) registered nurse (rn) was immediately notified.Approximately 0.5ml of air and 5ml old blood removed from lumen with fresh 10ml syringe without resistance.There was patient involvement bur harm was not reported as a consequence of this event.

• 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24519764
• Report Number: 9617594-2026-00220
• Device Sequence Number: 9723246
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)300501(10)14425600
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: 14425600
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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