MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE¿ CLEAR CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 011-MC100

Device Problems Break (1069); Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event involved a microclave clear connector where it was reported the connector broke while disconnecting from the fluid administration set.The broken piece got stuck inside the administration tubing and the nurse could not connect the intravenous (iv) set to another connector as the part was stuck inside the infusion set.The iv set got disconnected and leaked the medication which was noticed immediately but took time to prime another iv set with medication to recommence on the sedative agents.The status of the patient at the time of the event was fully sedated with sedative agent to manage high intracranial pressure (icp).A medication bolus dose was given by syringe to manage the lack of sedative agents.There was no harm reported but could not continue with sedation for a few minutes as the connector was part of the sedative medication line.The set was replaced and the therapy resumed but the event caused a short rise in icp.

Manufacturer Narrative

Received one new.List #011-mc100, microclave¿ clear connector; lot #5825000.One used.List #011-mc100, microclave¿ clear connector; lot #5825000.One used.Manufacturer unknown, extension set; lot #unknown.One used.List #unknown, fresofol 1% mct/lct 1000mg/100ml; lot #16ra3211.A used 011-mc100 microclave clear connector was returned and confirmed with the female luer portion of the assembly broken off typical of environmental stress breakage.The new 011-mc100 microclave clear connector was pressure leak tested without leakage or breakage.The probable cause of the female luer breakage of the 011-mc100 microclave clear connector is typical of environmental stress breakage during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: MICROCLAVE¿ CLEAR CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 16085915
• MDR Text Key: 308498905
• Report Number: 9617594-2023-00001
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K970855
• 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: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011-MC100
• Device Catalogue Number: 011-MC100
• Device Lot Number: 5825000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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: INTRAVENOUS INFUSION SET, UNK MFR; PROPOFOL, UNK MFR