MAUDE Adverse Event Report: COVIDIEN KANGAROO CONNECT FEEDING SET 500 ML; PUMP, INFUSION, ENTERAL

Model Number	77500FD
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer states their daughter uses the kangaroo connect pump with the 500 ml bags for feeding with her nasogastric (ng) tube.Over the past few weeks, several bags were leaking at the junction where the tube enters and exits the cassette.
Additional Manufacturer Narrative
Additional information : the device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and quality documentation.No sample was returned for evaluation, but a picture was provided by the customer.Examining the picture, leaking can be seen between the line and the cassette.An exact root cause cannot be determined without a physical sample to evaluate.The complaint will be reopened if a sample is received at a later date.No formal investigation action is being taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: KANGAROO CONNECT FEEDING SET 500 ML
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10246028
• Report Number: 1282497-2020-09184
• Device Sequence Number: 572836
• Product Code: LZH
• UDI-Device Identifier: 10884521190849
• UDI-Public: 10884521190849
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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
• Operator of Device: No Information
• Device Model Number: 77500FD
• Device Catalogue Number: 77500FD
• Device Lot Number: 191510048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 09/28/2020
• Patient Sequence Number: 1