MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO® CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 011-D1005

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  malfunction  

Event Description

The event involved a tego® connector where the customer reported that the connector did not seal vascular accesses and dialysis machine connections, causing blood leakage and problems with treatment.The event occurred during dialysis therapy with a patient.The therapy was interrupted with patient's blood loss (mild) due to erratic connections.Regarding the medication, there are no details, just it was a filter therapy of metabolic and essential ions.The therapy was restarted correctly without tego (delayed in time).There was patient involvement but no report of patient harm.

Manufacturer Narrative

The device has been requested to be returned for evaluation; however, it has not yet been received.

Manufacturer Narrative

Complaint of disconnection / loose connection can be confirmed based on the photos shared by the customer.However, since the used sample observed on the photo was not returned for evaluation, a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history report (dhr) for lot#13672740 was reviewed and no non conformities were found that would have led the reported condition on the complaint.

• Brand Name: TEGO® CONNECTOR
• Type of Device: 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: 18323260
• MDR Text Key: 330964556
• Report Number: 9617594-2023-01149
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619077051
• UDI-Public: (01)00840619077051(17)280601(10)13672740
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 011-D1005
• Device Lot Number: 13672740
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ESSENTIAL IONS, MFR UNK; FILTER THERAPY OF METABOLIC, MFR UNK; UNSPECIFIED DIALYSIS MACHINE, MFR UNK