MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 33" EXT SET W/2 CLAVE¿ CLEAR, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number MC33386

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.D4 - lot #: possible lot# 13825081.

Event Description

It was reported that, on an unknown date, a 33" ext set w/2 clave¿ clear, rotating luer generated a leak during patient use.As per the report, the tubing gave way, this incident only happened once.Since then, they have used all the tubing from this batch without further incident.The burst tubing (leaked tubing) was discovered when blood was discovered in the patient's bed.They quickly noticed the patient lost a few ml of blood through the tube, but nothing more.No incident report has been made.The tubing was replaced and therapy was resumed, the customer expressed that there was no other option.There was no patient harm reported.

• Brand Name: 33" EXT SET W/2 CLAVE¿ CLEAR, ROTATING LUER
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19102794
• MDR Text Key: 340809879
• Report Number: 9617594-2024-00428
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC33386
• Device Lot Number: 13825081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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: UNSPECIFIED FLUID, UNK MFR