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

Model Number 773662

Device Problem Air/Gas in Device (4062)

Patient Problem Abdominal Distention (2601)

Event Type  malfunction  

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 Description

The customer states that there are air gaps of 3 to 4 inches.The user has experienced bloating and occasional diarrhea.

• 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: 11656430
• MDR Text Key: 245136010
• Report Number: 1282497-2021-10048
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• 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
• Date Manufacturer Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1