MAUDE Adverse Event Report: ZEVEX INC. MOOG INFUSION ADMINISTRATION SET TUBING CURLIN 1.2M FILTER TUBING; PUMP, INFUSION, ENTERAL

Model Number 340-4128-V

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2020

Event Type  malfunction  

Event Description

While priming curlin 1.2m filter tubing prior to patient connection, the tubing started leaking at the filter.This occurred on multiple bags/tubings.Curlin 1.2m filter tubing lot # 2003502.Fda safety report id #: (b)(4).

• Brand Name: MOOG INFUSION ADMINISTRATION SET TUBING CURLIN 1.2M FILTER TUBING
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): ZEVEX INC.; salt lake city UT 84123
• MDR Report Key: 10105015
• MDR Text Key: 194050952
• Report Number: MW5094765
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 340-4128-V
• Device Lot Number: CF2003502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 53