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

Model Number 762055

Device Problem Improper Flow or Infusion (2954)

Patient Problem Discomfort (2330)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

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 air was accumulating in the tubing (air space is between 6 to 8 inches).The patient fed three times a day: 1st feed was 80ml/hour from 6am to 11am 500ml volume; second feed was 100ml/hour from 12pm to 6pm (feed n flush) 500ml volume plus 100ml water; third feed was 80ml/hour from 9pm to 4am.The length of the feed has not changed while having issues.The customer further stated that they are using a "g-tube" delivery and the pump set was changed every 2 weeks.The issue was discovered during use.No error message was appeared on the pump.The patient was not overfed or underfed during the incident.The patient felt discomfort due to air going into the stomach.

• Brand Name: JOEY 500ML PUMP 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: 10942874
• MDR Text Key: 219547303
• Report Number: 1282497-2020-09763
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521072299
• UDI-Public: 10884521072299
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 762055
• Device Catalogue Number: 762055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1