MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.68 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 2 CHEC; STOPCOCK, I.V. SET

Model Number MC33687

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.

Event Description

The event involved a 4" (10 cm) appx 0.68 ml, smallbore trifuse ext set w/3 microclave clear, 2 check valve, 3 clamps (2 white, red), rotating luer in which the reporter stated that there was a leakage between the bonded needleless connector and the iv tubing.The leaking was observed at the bonded microclave, where the primary tubing is attached and the center of the needleless connector.The customer reported that there was a loose connection between the alaris iv tubing the fixated microclaves on the connector.Nurse described that norepinephrine (a vasopressor) was infusing through the line, during patient infusion/procedure and iv tubing leaked and disconnected from the microclave.There was patient involvement, but there was no reported harm as a consequence of this event.

Manufacturer Narrative

One open/unused device list #mc33687, 4" (10 cm) appx 0.89 ml, smallbore trifuse ext set w/3 microclave¿ clear, 2 check valve, 3 clamps (2 white, red), rotating luer; lot #7154218 was received for evaluation on 12/8/2022.There were no visual anomalies or damage observed.The used trifuse extension set was pressure leak tested at each of the proximal and distal connection points.No leakage was observed at any location or connection during testing.The complaint was unable to be replicated or confirmed during lab testing.The lot history of the provided sample was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 4" (10 CM) APPX 0.68 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 2 CHEC
• 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: 15826273
• MDR Text Key: 304010116
• Report Number: 9617594-2022-00304
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC33687
• Device Catalogue Number: MC33687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• 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: ALARIS PUMP INFUSION SET REF2420-0007, MFR BD; NOREPINEPHRINE, MFR UNK