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

Catalog Number D1005

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without a returned sample, the probable cause cannot be determined.The lot number is unknown, therefore, a device history review cannot be performed.If additional information becomes available a supplemental report will be submitted.

Event Description

A user facility mandatory medwatch (# (b)(4)) was received for an event that occurred in the pediatric intensive care unit (picu) and involved a tego needleless safety connector that ¿disconnected¿ during a ¿respiratory treatment¿ resulting in approximately 30ml of blood loss.The nurse entered the room when the circuit alarmed and found the return line in the bed.The machine was paused, the hub was scrubbed, the line was reconnected, and the therapy was restarted.The nurse practitioner and fellow were notified and arrived at the bedside.Antibiotics were ordered and a complete blood count was drawn.

• Brand Name: TEGO® CONNECTOR
• Type of Device: SET, ADMINISRATION, 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: christopher zanoni ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 9438904
• MDR Text Key: 187698725
• Report Number: 9617594-2019-00416
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D1005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 6 YR