MAUDE Adverse Event Report: COVIDIEN EPUMP 1000ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number	773656
Medical Device Problem Codes	Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
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.
Event or Problem Description
The customer reported air bubbles with the enteral feeding set.No patient injury was reported.
Additional Manufacturer Narrative
Corrected the & nbsp;medical device problem code in section h6 from 1250 leaking to 4062 air/gas in device.Brbr.
Additional Manufacturer Narrative
Investigation summary: the customer reported air bubbles with the enteral feeding set.No patient injury was reported.A review of the device history record was unable to be completed as the lot number reported was unknown.A trend review of the reported failure identified no trends.One used sample was received for evaluation.Visual inspection and functional testing performed confirmed the reported complaint of air in the line.A potential root cause related to manufacturing was noted.An investigation has been initiated to determine the root cause of this device failure.This product issue will continue to be monitored and trended.

• Brand Name: EPUMP 1000ML PUMP SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11004782
• Report Number: 1282497-2020-09782
• Device Sequence Number: 3813401
• Product Code: LZH
• UDI-Device Identifier: 10884521022096
• UDI-Public: 10884521022096
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 03/02/2021

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: 773656
• Device Catalogue Number: 773656
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 12/11/2020; 12/11/2020
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 12/15/2020; 03/02/2021
• Patient Sequence Number: 1