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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.
Event or Problem Description
The event occurred on an unspecified date in (b)(6) 2025 and involved a tego connector.It was reported that tego did not have a proper connection, and that they shuttered, bearing the danger that these shuttered parts could enter the patient's blood stream.The rubber part was cut off the product during priming and infusion.There was an involved patient that was unaware of the problem.
Additional Manufacturer Narrative
D9 - date returned to mfr: 27apr2026 investigation summary five (5) new.List #d1000, tego¿ connector, appx 0.05 ml; lot #14376313 were returned for evaluation.As received, no damage, anomalies, shattered pars or cracks along the sets were observed, no mating device was returned for evaluation.The brand new samples were leak and vacuum tested and met the product specifications.The male luer met the iso design specification.The complaint of disconnection / loose connection could not be replicated using the new tego samples.However, based on the lot number and the described failure mode, the complaint is confirmed.The probable cause was due to an inconsistent amount of silicone lubricant on the tego seal and adhesive not being applied consistently at the specified points on the housing according to procedure.The lot history was reviewed and 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: 24466620
• Report Number: 9617594-2026-00203
• Device Sequence Number: 10308348
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)300401(10)14376313
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2026

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: 14376313
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 04/27/2026; 05/29/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/14/2026; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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