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

Model Number 763662

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problem Discomfort (2330)

Event Date 03/06/2021

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.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 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
• 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: 11710406
• MDR Text Key: 246984113
• Report Number: 1282497-2021-10096
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521072312
• UDI-Public: 10884521072312
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 763662
• Device Catalogue Number: 763662
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Type of Device Usage: N
• Patient Sequence Number: 1