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	No Flow (2991)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A event was received regarding a tego® connector in which it was reported that they had difficulty maintaining blood flow at onset of treatment, and the patient developed an infection.Following troubleshooting found no further issue with blood flow once tego cap removed from catheter.New tego placed on catheter at end of treatment.Home hemo patient receiving treatments at the dialysis facility.There was no medication administered, only hemodialysis treatment.It was infused via central line catheter.Iv antibiotics administered after blood cultures obtained.Patient hospitalized on (b)(6) 2025 for cardiac workup to rule out endocarditis patient received 6 weeks of iv antibiotics and has now recovered.No defect observed on tego.Catheter replaced.The patient received full hemodialysis treatment once the tego connector was removed.Bacteremia resolved following course of iv antibiotics.There was no delay in treatment.
Additional Manufacturer Narrative
The device has been requested for evaluation- it has not been received.The investigation is pending.
Additional Manufacturer Narrative
D9: date returned to mfr: 2/27/2026.Sixteen (16) brand-new tego¿ connectors, appx 0.05 ml.Lot#: 14226013 were returned for evaluation.As received, no damage or anomalies were observed.No mating device was returned for evaluation.The whole 15 samples met the product specification after been tested.The complaint was not able to be replicated.Based on the lot number, this was already included in a capa scope.The complaint can be confirmed.The probable cause is due to an 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.A corrective and preventative action (capa) plan has been implemented to address the identified issue.The outcome of the capa is currently under evaluation and is not yet finalized the device history review (dhr) was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.
Additional Manufacturer Narrative
Corrected information can be found in b6 - relevant test/laboratory data, e3 - initial reporter occupation, h6 health effect - impact codes, h6 component codes, h7 and h9.

• 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: 24345505
• Report Number: 9617594-2026-00145
• Device Sequence Number: 21342350
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)291201(10)14226013
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D1000
• Device Lot Number: 14226013
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/18/2026; 04/17/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/26/2026; 05/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2024
• 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: UNSPECIFIED CENTRAL LINE CATHETER, MFR UNKNOWN.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic