MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 18"(46 CM)APPX 2.5ML, EXT SET W/PREPIERCED PORT, EASYDROP FLOW CNTLLER, ROT LUER; STOPCOCK, I.V. SET

Catalog Number 117420460

Device Problem Inaccurate Delivery (2339)

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

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

No product samples, videos, or photographs were provided for investigation.A device history record (dhr) review could not be conducted because no lot number was identified.A probable cause cannot be identified based on the information that has been provided.

Event Description

The event involved a 18" (46 cm) appx 2.5 ml, ext set w/pre-pierced port, easydrop flow controller, rotating luer.The customer reported an issue with the dial-a-flow device during an infusion on a patient.The nurse reported that the infusion rate was set at 75ml/hr for a 1 liter bag; however, a lot of solution remaining in the bag the next day.The nurse did not specifically indicate how long into the duration of the infusion that the issue was identified and also did not specify how much liquid remaining in the bag.There was no human harm or injury.

• Brand Name: 18"(46 CM)APPX 2.5ML, EXT SET W/PREPIERCED PORT, EASYDROP FLOW CNTLLER, ROT LUER
• 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: 14167907
• MDR Text Key: 289761784
• Report Number: 9617594-2022-00084
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 117420460
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: RINGERS LACTATE, MFR UNK