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

Model Number 762055

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported air bubbles in the line.

Manufacturer Narrative

The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Four used sample were received for evaluation.Visual and functional inspection was performed and found air in the line.Root cause and action plan will be documented through a formal corrective and preventative action investigation.These actions will be designed to prevent the reoccurrence of the reported issue.

• Brand Name: JOEY 500ML PUMP SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10810190
• MDR Text Key: 215322556
• Report Number: 1282497-2020-09612
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521072299
• UDI-Public: 10884521072299
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• 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
• Device Lot Number: 201250127
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/06/2020
• Patient Sequence Number: 1