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

Catalog Number D1000

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 11/11/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it has not yet been received.E1 - (b)(4).

Event Description

The event involved a atego® connector where the customer reported a tear at the slit of the silicone sleeve".The event occurred during a dialysis treatment.There was patient involvement, but harm was not reported as a consequence of this event.

Manufacturer Narrative

No product samples, videos, or photographs were provided for investigation.A probable cause cannot be identified based on the information that has been provided.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: TEGO¿ CONNECTOR
• Type of Device: SET, INTRAVASCULAR, ADMINISTRATION
• 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: 18470304
• MDR Text Key: 332526508
• Report Number: 9617594-2024-00015
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• 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