MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. APPX 0.36 ML, 3-WAY STOPCOCK W/MICROCLAVE® CLEAR, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number 011-MC33538

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event involved a appx 0.36 ml, 3-way stopcock w/microclave® clear, rotating luer where it was reported the connector had a crack in the tip, which caused a problem with the patient's anesthesia and led to the patient waking up during the procedure.The event occurred during patient use; however, no one was reported harmed as a result of this event.When the product leaked, it interfered with the anesthetic process, causing the patient to wake up and requiring a bolus of propofol to return the patient to anesthetic state.

Manufacturer Narrative

One (1) photo was shared where a crack is observed on the stopcock, however no leaks are observed on the photo.One (1) used.List #011-mc33538 stopcock sample was returned for evaluation.As received a crack and crazing were observed.No mating device was returned.Complaint of leaks can be confirmed based on the crack and the crazing.The probable cause of the cracks is typical due to environmental stress during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: APPX 0.36 ML, 3-WAY STOPCOCK W/MICROCLAVE® 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: 18922984
• MDR Text Key: 337890218
• Report Number: 9617594-2024-00279
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619072438
• UDI-Public: (01)00840619072438(17)280401(10)13605557
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K080077
• 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,Followup
• Report Date: 05/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC33538
• Device Lot Number: 13605557
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2023
• 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: PROPOFOL, MFR UNK.