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

Model Number	384400
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the volume is always not precise and the unit sometimes pumps air/bubbles into the tubing.
Additional 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
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9618127
• Report Number: 1282497-2020-08876
• Device Sequence Number: 2738421
• Product Code: LZH
• UDI-Device Identifier: 10884521190894
• UDI-Public: 10884521190894
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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
• Operator of Device: No Information
• Device Model Number: 384400
• Device Catalogue Number: 384400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1