MAUDE Adverse Event Report: COVIDIEN EPUMP 500ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number	772055
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
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 there was air in the tubing of the feeding set.There was no patient harm.
Additional Manufacturer Narrative
Additional information: h2, h3, h6.Investigation summary: the customer reported air in the enteral feeding tubing.No patient injury was reported.A device history record review was unable to be completed as the lot number was unknown.One (1) used device was returned for evaluation.Visual inspection and functional testing confirmed the reported issue of air in line.An investigation has been initiated to determine the root cause of this device failure.The root cause and conclusion of the confirmed device failure will be documented within the investigation.This product issue will continue to be monitored and trended.

• Brand Name: EPUMP 500ML PUMP SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11095919
• Report Number: 1282497-2020-09819
• Device Sequence Number: 19758098
• Product Code: LZH
• UDI-Device Identifier: 10884521023925
• UDI-Public: 10884521023925
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 03/01/2021

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: No Information
• Device Model Number: 772055
• Device Catalogue Number: 772055
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 03/01/2021
• Patient Sequence Number: 1