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

Model Number UNK EF

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 3/21/2018.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that there was a hole in the tubing of the enteral feeding pump set and liquid leaked onto the pump.

Manufacturer Narrative

No sample available.A dhr review could not be performed.A review of the complaint history for this part number could not be performed since no valid part number was provided.Since the sample was not provided for evaluation the failure mode could not been confirmed.The root cause and corrective actions could not be identified.This complaint will be closed with no further action; if sample is received later, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 37 insurgentes blvd; tijuana 22225 ; MX 22225
• Manufacturer (Section G): COVIDIEN; 37 insurgentes blvd; tijuana 22225 ; MX 22225
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7358662
• MDR Text Key: 103083927
• Report Number: 1282497-2018-00204
• Device Sequence Number: 1
• Product Code: LZH
• 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,Followup
• Report Date: 08/31/2018

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: Health Professional
• Device Model Number: UNK EF
• Device Catalogue Number: UNK EF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 02/23/2018
• Supplement Dates FDA Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1