MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. KIT, 2 EXT SET, STANDARD/SMALLBORE, 4-GANG STOPCOCK, 11 CLAVE¿ CLEAR, 3 STOPCOCK; STOPCOCK, I.V. SET

Catalog Number 011-MC330680

Device Problem Break (1069)

Patient Problem Ventilator Dependent (2395)

Event Date 03/04/2022

Event Type  Death  

Manufacturer Narrative

The device is available for evaluation; however, it has not yet been received.

Event Description

The event took place on (b)(6) 2022 in the intensive care unit (icu) and involved an unspecified disposable device.The icu medical line broke following a hernia (bulge/protrusion) that occurred in the tubing during the injection of a high-kinetic contrast product on the proximal stopcock.There were no physical defects noted on the device before the incident.Due to the incident, therapy was not completed, and the scan could not be performed.It was necessary to re insert a peripheral venous line to carry out the scan.The patient was sedated, intubated, and ventilated during and after the event.Deterioration of the patient eventually lead to death.However, it was stated by the icu nurse that ¿the patient presumably showed no consequences of the incident and died of another cause.¿.

Manufacturer Narrative

No product samples, videos, or photographs were provided for investigation.After multiple attempts to try and get sister samples for investigation as required by a level 3 investigation, the attempts were unsuccessful.No device history review (dhr), lot review was conducted because no lot number(s) was/were identified.A probable cause cannot be identified based on the information that has been provided.

Manufacturer Narrative

Icu med received an email from the customer on 4/26/2023 notifying us that the event on this record is a duplicate of cn-199124 / 9617594-2023-00106.Both cn-199124 / mdr 9617594-2023-00106 and cn-150754 / mdr 9617594-2022-00062 is the same incident involving the same patient.This record will be closed and all information including the investigation will be submitted in a supplemental report under cn-199124 / 9617594-2023-00106.

• Brand Name: KIT, 2 EXT SET, STANDARD/SMALLBORE, 4-GANG STOPCOCK, 11 CLAVE¿ CLEAR, 3 STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13876467
• MDR Text Key: 287771852
• Report Number: 9617594-2022-00062
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• 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,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC330680
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• 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
• Treatment: HIGH KINETIC CONTRAST, MFR UNK
• Patient Outcome(s): Death