MAUDE Adverse Event Report: COVIDIEN JP KANGAROO JOEY PUMP X1; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 983400

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2019

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.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 that the actual feeding quantity does not match with the setting quantity.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed.All device history records are reviewed for quality inspections and compliance prior to releasing the product for shipment.A functional test and visual inspection were completed, and the reported issue is not confirmed.The root cause of the reported condition could be identified.Therefore, a corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: JP KANGAROO JOEY PUMP X1
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9428491
• MDR Text Key: 169671247
• Report Number: 1282497-2019-08808
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• 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,Followup
• Report Date: 01/31/2020

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
• Device Operator: No Information
• Device Model Number: 983400
• Device Catalogue Number: 983400
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 11/29/2019; 11/29/2019
• Supplement Dates FDA Received: 01/31/2020; 02/01/2020
• Patient Sequence Number: 1