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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a tego¿ connector.It was reported that the tego plug was attached to the arterial line of a properly secured dialysis catheter; however, blood was observed flowing through the plug.The tego connector was found to be defective around the protective plastic membrane.There was patient involvement, but no patient harm was reported.
Additional Manufacturer Narrative
The device has been requested for evaluation; it has not been received.The investigation is pending.
Additional Manufacturer Narrative
One used.List #d1000, tego¿ connector, appx 0.05 ml.As received, the device's seal collapsed and a tear around the seal was observed.No mating device was returned for evaluation.The sample was leak and vacuum tested and passed all the testing.Even though the sample passed the functional test and no leaks were noted, the customer's complaint of leakage can be confirmed based on the returned used tego.The probable cause is due to inconsistent amount of silicon lubricant on the tego seal and adhesive not being applied consistently at the specified points on the housing according to procedure.The device history record (dhr) was reviewed and no nonconformities were found that would have led to the reported complaint.D9 - date returned to mfr: 19feb2026.
Event or Problem Description
Additional information: the product was kept in its original packaging in the facility's warehouse.

• 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: 24378795
• Report Number: 9617594-2026-00156
• Device Sequence Number: 13314080
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)300201(10)14321159
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/15/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTERIAL LINE, MFR UNK; DIALYSIS CATHETER, MFR UNK; UNSPECIFIED DIALYSIS MACHINE, MFR UNK
• Patient Sex: Unknown