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

Catalog Number D1000

Device Problems Fluid/Blood Leak (1250); Air/Gas in Device (4062)

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

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Additional contact information: (b)(6).

Event Description

The event involved a tego¿ connector which includes the following customer report.The valve tego was fitted on monday 8 march for a period of 7 days.On the friday after his dialysis session, the patient got up and the nurse noticed blood leaking from his dialysis catheter dressing, which she had just redone.The venous side was beading with blood, so the nurse clamped the catheter and had the patient lie down again.She then sucked out the air that had entered the catheter and put classic plugs on the catheter.Leak problem after closing the lock.The status of the product at the time of event is after the patient's dialysis session.The type of procedure was hemodiafiltration (hdf) post, the products used during the therapy were: erythropoietin (epo) and heparin, the blood loss was under 50ml.There was no delay in therapy, no adverse operator consequences, medical/surgical intervention was not required and that the current status of the patient is returned to baseline condition.There was patient involvement but no adverse event.The customer confirmed the event date is (b)(6) 2024.

• 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: 19042883
• MDR Text Key: 340130879
• Report Number: 9617594-2024-00365
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)280601(10)13672538
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• 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: 13672538
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• 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: CATHETER DRESSING, MFR UNK; CATHETER, MFR UNK; CLASSIC PLUGS, MFR UNK; ERYTHROPOIETIN (EPO), MFR UNK; HEPARIN, MFR UNK
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 63 KG