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

Model Number 773662

Device Problem Air/Gas in Device (4062)

Patient Problems Flatus (1865); Nausea (1970); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that they have been dealing with excess air in the tubing on a regular basis which has exacerbated their gi issues.Additional information provided by the customer stated that the issue has been intermittent and ongoing.The customer has had symptoms of nausea, windy and bloating.The customer did not require any treatment or intervention for the reported incident and did not see a health care professional for these issues.

• Brand Name: EPUMP FEED AND 1000MLFLUSH SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11592931
• MDR Text Key: 243184942
• Report Number: 1282497-2021-10021
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 30884521022106
• UDI-Public: 30884521022106
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 773662
• Device Catalogue Number: 773662
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1