MAUDE Adverse Event Report: COVIDIEN UNKNOWN ENTERAL FEEDING DURABLES; PUMP, INFUSION, ENTERAL

Model Number UNKNOWN ENTERAL ACCESS DURABLES

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Date 01/22/2021

Event Type  malfunction  

Event Description

The customer reported that the enteral feeds are not accurate and the pump is infusing too fast.

• Brand Name: UNKNOWN ENTERAL FEEDING DURABLES
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11474810
• MDR Text Key: 239478681
• Report Number: 1282497-2021-09971
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN ENTERAL ACCESS DURABLES
• Device Catalogue Number: UNKNOWN ENTERAL ACCESS DURABLE
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/12/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1