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

Model Number 384400

Device Problem Improper Flow or Infusion (2954)

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

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample 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 volume is always not precise and the unit sometimes pumps air/bubbles into the tubing.

Manufacturer Narrative

After further review of the complaint details it was determined that this report was submitted in error as the incident does not meet the mdr regulation requirements of a reportable event.

• Brand Name: CONNECT FEEDING PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9618127
• MDR Text Key: 176033853
• Report Number: 1282497-2020-08876
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521190894
• UDI-Public: 10884521190894
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 384400
• Device Catalogue Number: 384400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Patient Sequence Number: 1