MAUDE Adverse Event Report: ICU MEDICAL LOPEZ VALVE ENTERAL TETHERED CAP; TUBE, FEEDING

Catalog Number M9000-T

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2020

Event Type  malfunction  

Event Description

Medication and feeding leaking out of the connection between the valve and where it connects to the weighted tube to the patient.

• Brand Name: LOPEZ VALVE ENTERAL TETHERED CAP
• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): ICU MEDICAL; 600 n field dr; lake forest IL 60045
• MDR Report Key: 10918971
• MDR Text Key: 218685594
• Report Number: 10918971
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M9000-T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1