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

Model Number 775659

Device Problems Hole In Material (1293); Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion, the results will be forwarded.

Event Description

It was reported to covidien on 9/19/2016 that a customer had an issue with an enteral feeding pump set.The customer reports that when the nurse pierced the bag, the liquid was dripping from the mouth to the outside of the tubing.The device will be returned for evaluation.

Manufacturer Narrative

Submit date: 05/16/2017.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One used sample and 67 unused samples were received for evaluation.A functional test and visual inspection was performed and the reported issue was confirmed on the used sample.There were no issues found with the unused samples.A root cause can be due to a dimensional gap between the cross spike connector and tubing.A formal corrective and preventative action was implemented for the reported issue.This complaint will be used for tracking and trending purposes.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that when the nurse pierced the bag, the liquid was dripping from the mouth to the outside of the tubing.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 37 insurgentes blvd; a la p, la mesa; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; 37 insurgentes blvd; a la p, la mesa; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6003460
• MDR Text Key: 57252102
• Report Number: 1282497-2016-00786
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 775659
• Device Catalogue Number: 775659
• Device Lot Number: 153520141X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1