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

Model Number UNKNOWN ENTERAL FEEDING DURABLES

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

The product id and serial number were not provided.As a result, the udi could not be identified.To date the incident device has not been received for evaluation.  if the device is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

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: 11474302
• MDR Text Key: 239449304
• Report Number: 1282497-2021-09968
• 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

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