MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. KIT COMPOSED OF 4 GANG STOPCOCK W/5 MICROCLAVE® CLEAR, POLE MOUNT, 150 CM EXT W/; STOPCOCK, I.V. SET

Catalog Number 011-MC33416

Device Problem Air/Gas in Device (4062)

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

Event Date 03/04/2023

Event Type  malfunction  

Event Description

The event involved a kit composed of 4 gang stopcock w/5 microclave® clear, pole mount, 150 cm ext w/2 rotating luers (male/male) where a customer reported a recurring incident of a leak at the level of the red stopcock and formation of an air bubble in the tubing during patient use-infusion.The drug that leaked was nutrition.The bubble was observed in the tubing.Fortunately, the air bubble was not in contact with the patient.There were no air eliminator filter used.There was patient involvement but no harm, no blood loss considered clinically significant, no need for medical intervention, and no delay in therapy.

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.

Manufacturer Narrative

Additional information for d9 - date returned to mfg is 8/29/2023.A leak was confirmed at a crack in the inline female luer of the 011-mc33416 manifold.The probable cause is typical of unintended bending force during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: KIT COMPOSED OF 4 GANG STOPCOCK W/5 MICROCLAVE® CLEAR, POLE MOUNT, 150 CM EXT W/
• 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: 16583847
• MDR Text Key: 311853368
• Report Number: 9617594-2023-00118
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619069353
• UDI-Public: (01)00840619069353(17)270801(10)8130742
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC33416
• Device Lot Number: 8130742
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• 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 NUTRITION INFUSION, MFR UNK