MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY,PUMP W/CLMP,REFB; PUMP, INFUSION, ENTERAL

Model Number 383401

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned pump s/n (b)(4) was received damaged and front case was cracked.The device was manufactured in 2007 and this the first time this serial number was returned for service therefore the reported event was determined to be caused by customer mishandling of the device.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.

Event Description

The customer reported that the device had fire damage.

• Brand Name: KANGAROO JOEY,PUMP W/CLMP,REFB
• 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 ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12072815
• MDR Text Key: 258850705
• Report Number: 1282497-2021-10384
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521144019
• UDI-Public: 10884521144019
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 383401
• Device Catalogue Number: 383401
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1