MAUDE Adverse Event Report: COVIDIEN JOEY 1000ML FEED/FLUSH SET; PUMP, INFUSION, ENTERAL

Model Number	763662
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/06/2021
Type of Reportable Event	Malfunction
Additional 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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.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 at approximately 4:30 the pump was started per usual for a feeding.The distal line was occluded, resulting in a spillage of formula.This is not a first-time occurrence, it happens all the time if the distal end is occluded by clamping.When tested in a test environment it occurs at least 75% of the time.Additional information received stated the leaking occurred at the distal tip of the feeding set.

• Brand Name: JOEY 1000ML FEED/FLUSH SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11710406
• Report Number: 1282497-2021-10096
• Device Sequence Number: 3999120
• Product Code: LZH
• UDI-Device Identifier: 10884521072312
• UDI-Public: 10884521072312
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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: 763662
• Device Catalogue Number: 763662
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 04/22/2021
• Patient Sequence Number: 1