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 Material Split, Cut or Torn (4008)

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

Event Date 02/04/2023

Event Type  Death  

Manufacturer Narrative

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

Event Description

The event involved a kit, 2 ext set, standard/smallbore, 4-gang stopcock, 11 clave¿ clear, 3 stopcocks where it reported that during an injection of iodine at the scanner, from the proximal stopcock, the downstream line "exploded" under the pressure of injection at the proximal level.The clinical consequences noted was that there was a high risk of gas embolism for the patient because there was no venous return.The scanner was not performed.There was a need to rest the peripheral venous line to perform the scanner injection; the blood was drawn to avoid gas embolism; the line was rinsed.There was a high risk of infection due to the opening of the line; change of crimped lines when returning from the scanner.There was patient involvement.Additionally, the customer reported that a vigilance declaration certificate was signed by a doctor stating that the death of the patient the following month is in no way related to this incident.It is unknown the exact date of when the patient expired.No further information was provided.

Manufacturer Narrative

D9 - date returned to mfg on 8/9/2023.The used 011-mc330680, kit, 2 ext set, standard/smallbore, 4-gang stopcock, 11 clave clear, 3 stopcocks assembly was confirmed to leak from a rupture in the tubing near the distal end.It was stated in the complaint that the rupture occurred during pressure injection.The 011-mc330680, kit, 2 ext set, standard/smallbore, 4-gang stopcock, 11 clave clear, 3 stopcocks assembly is not rated for pressure injection.The probable cause of the tubing rupture is typical of use in a high pressure injection application when the assembly was not rated for high pressure use.A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• 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: 16545447
• MDR Text Key: 311312751
• Report Number: 9617594-2023-00106
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: IODINE INJECTION, MFR UNK
• Patient Outcome(s): Death