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 Problem Disconnection (1171)

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

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The incident involved a tego¿ connector.The initial reporter stated that, during use with a patient, the connectors did not connect properly with the hemodialysis catheter.The connectors have spontaneously detached while the patient was connected to the equipment.The product was not contaminated and it was not reprocessed or re-sterilized.No medication was used while using the connector.The event occurred during patient use, there was delay in therapy, and no one was harmed as a result of this event.This is the first of two reported events.

Manufacturer Narrative

One new sample #(b)(6) was returned for evaluation.As received no physical damage or anomalies were confirmed.No mating device was returned for evaluation.The sample was measured for iso taper and thread design.This met iso 594-2 design guidance for luer and thread form.Complaint of components will not mate properly leaks cannot be confirmed or replicated.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported 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: 18238917
• MDR Text Key: 329556137
• Report Number: 9617594-2023-01055
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: HEMODIALYSIS CATHETER, MFR UNK; UNSPECIFIED HEMODIALYSIS MACHINE, MFR UNK