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

Catalog Number D1000

Device Problem No Flow (2991)

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

Event Date 12/10/2023

Event Type  malfunction  

Event Description

The event involved a tego¿ connector where the customer reported that when the staff hooked up the patient to the dialysis machine the arterial side was completely occluded so they had to change it.There was unknown patient involvement; harm was not reported as a consequence of this event.

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is not yet received.Other contact information: (b)(6).(b)(6).(b)(6).(b)(6).Reporter postal code: (b)(6).(b)(6) reference number - (b)(4).

Manufacturer Narrative

Device was returned for evaluation on 2/19/24.One (1) used sample item #(b)(4) was returned for evaluation.As received no physical damage on thread post damage or anomalies were observed.An occlusion on the fluid path was observed, however after the fluid path was flushed some pieces of blood clot came out, and no more visible occlusions were observed anymore, the seal was peeled off and no errant adhesive were confirmed.Complaint of no flow / cant prime/ difficult to prime can be confirmed.The probable cause is due to a blood clot during use.Lot history review 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: 18616927
• MDR Text Key: 334230326
• Report Number: 9617594-2024-00077
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)280601(10)13679313
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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: 13679313
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2024
• 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