MAUDE Adverse Event Report: COVIDIEN KANGAROO; PUMP, INFUSION, ENTERAL

Model Number 382400

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

The unit was received at the service center with a customer complaint of ¿unit has pole clamp issues with pole clamp and wont screw behind screw holder came off rear case might be broken¿.The complaint was verified as the pole clamp mount brass insert is missing and the case at the mount has several cracks.The determination of cause cannot be ascertained as there is no evidence available to support it or how it occurred.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer returned the unit for an issue with the pole clamp.The customer stated, "wouldn't screw behind screw holder came off rear case, might be broken".This was discovered during testing with no patient involved.Additional information has been requested with no response to date.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7345503
• MDR Text Key: 102899708
• Report Number: 2183870-2018-00155
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006614
• UDI-Public: 10884521006614
• 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: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1