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

Model Number 763656

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reported the feeding set was leaking from the spike connection.The feed was found dripping on the floor.

Manufacturer Narrative

H 3 evaluation summary no device history record (dhr) review could be performed because the lot number is unavailable.One used sample was received for evaluation.Visual and functional evaluation was performed, and the device was found to have a detached line from the cross spike.A photograph was also provided showing the detachment of the cross-spike connector.Root cause and action plan will be documented through a formal corrective and preventative action (capa).This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: JOEY 1000ML PUMP SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9530318
• MDR Text Key: 173036068
• Report Number: 1282497-2019-08847
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521072305
• UDI-Public: 10884521072305
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 763656
• Device Catalogue Number: 763656
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/19/2019
• Patient Sequence Number: 1