MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 211 CM (83") EXT SET W/4 GANG STOPCOCK, POLE MOUNT, 8 MICROCLAVE® CLEAR, 2 CHECK; STOPCOCK, I.V. SET

Catalog Number 011-MC330273

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)

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

Event Date 02/04/2024

Event Type  malfunction  

Event Description

The event involved a 211 cm (83") ext set w/4 gang stopcock, pole mount, 8 microclave® clear, 2 check valves, 4-way stopcock, rotating luer.The event happened at the intensive care unit.The installation of the infusion occurred at 12 a.M.At 8 p.M., the nurse noted the presence of air in the tubing between the manifold and the injection site.After checking, the nurse noted the presence of a leak at the output of the manifold and notes that the tubing is disconnecting.The manifold was not manipulated with pliers or forced manually.The drugs infused were olimel n12, glucose and insulin.The status of the product at the time of the event is during infusion.There was patient involvement.There was no impact on the patient's state of health.No adverse events, no human harm, no delay in therapy, no need of medical intervention.No visible default on the device before use.No cut, no tear, no hole on the device.The treatment has been resumed and medications fully administered.No need of medical intervention for the nurse.

Manufacturer Narrative

The device was received for evaluation.The investigation is pending.

Manufacturer Narrative

Received one used 011-mc330273 extension set for inspection.No damages, anomalies, or separations noted.Examination of the male luer of the manifold to the female luer of the tubing under uv light showed sufficient solvent coverage.The set was leak tested per product specifications.There was no leakage.The reported complaint of leakage could not be replicated or confirmed.A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 211 CM (83") EXT SET W/4 GANG STOPCOCK, POLE MOUNT, 8 MICROCLAVE® CLEAR, 2 CHECK
• 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: 18847037
• MDR Text Key: 337012676
• Report Number: 9617594-2024-00232
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC330273
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• 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: GLUCOSE, MFR UNK; INSULIN, MFR UNK; OLIMEL N12, MFR UNK