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

Model Number 773662

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2019

Event Type  malfunction  

Event Description

The customer reported that the nutrition bag presented a leak where the water is installed.The patient was involved, but there was no patient injury, medical intervention, or adverse reaction.

• 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: 9341526
• MDR Text Key: 168605917
• Report Number: 1282497-2019-08781
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 30884521022106
• UDI-Public: 30884521022106
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2019

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
• Device Operator: No Information
• Device Model Number: 773662
• Device Catalogue Number: 773662
• Device Lot Number: 191860086
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1