MAUDE Adverse Event Report: COVIDIEN EPUMP FEED AND 1000MLFLUSH SET; PUMP, INFUSION, ENTERAL

Model Number	773662
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
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 there was a nutrition leak through a side hole during use with a patient with enteral nutrition order.There was patient involvement; but no patient injury, medical intervention or adverse reaction was reported associated with this event.
Additional Manufacturer Narrative
A digital image was provided for evaluation.Based on the digital image it is not possible to confirm the reported issue.The physical sample is required to evaluate the reported condition.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the problem described.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Since a sample was not returned for evaluation and the reported issue was not confirmed, the root cause for the reported condition cannot be specifically identified; therefore, corrective action will be limited to the manufacturing awareness at this time.Please note that the current process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: EPUMP FEED AND 1000MLFLUSH SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11987987
• Report Number: 1282497-2021-10267
• Device Sequence Number: 19689513
• Product Code: LZH
• UDI-Device Identifier: 30884521022106
• UDI-Public: 30884521022106
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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
• Operator of Device: Health Professional
• Device Model Number: 773662
• Device Catalogue Number: 773662
• Device Lot Number: 2100210864
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 09/29/2021
• Patient Sequence Number: 1