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

Model Number	762055
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; 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 or Problem 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 6 am to 11 am 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
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10975408
• Report Number: 1282497-2020-09769
• Device Sequence Number: 4294980
• Product Code: LZH
• UDI-Device Identifier: 10884521072299
• UDI-Public: 10884521072299
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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: 762055
• Device Catalogue Number: 762055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 12/09/2020
• Patient Sequence Number: 1