MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE® CLEAR, R; STOPCOCK, I.V. SET

Model Number MC33892

Device Problem Inaccurate Delivery (2339)

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

Event Date 01/10/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A device history review could not be completed due to the unknown lot number.

Event Description

The event involved a 107" (272 cm) appx 8.7 ml, transfer set w/dual check valve, microclave® clear, rotating luer which was received via a user facility mandatory medwatch report # (b)(4) and stated: "closed medication administration infusion set being utilized on unit for medication administration with flush to follow for infusion via central lines.Unit has experienced three events in last month where normal saline bag attached to set, intended to allow for flush fluid to be pulled into syringe via one way valve has inadvertently infused into the patient.Volume of 90-180ml additional administered over several hours that was not intended." there was patient involvement, however, no harm was reported as a consequence of this event.

• Brand Name: 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE® CLEAR, R
• 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: 13928269
• MDR Text Key: 297948411
• Report Number: 9617594-2022-00064
• 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
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC33892
• Device Catalogue Number: MC33892
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NORMAL SALINE, MFR UNK
• Patient Age: 17 MO
• Patient Sex: Male
• Patient Weight: 10 KG
• Patient Race: White