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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that the end user experienced pump set tubing coming apart at the cassette, especially when priming.Additional information received from the customer stated that there was a leak as the tubing was disconnected.There was no patient harm reported.
Additional Manufacturer Narrative
Additional information: h2, h3, h6.Investigation summary: the customer reported the pump set tubing was coming apart at the cassette when priming.Additionally, leaking occurred when the tubing disconnected.A review of the device history record was unable to be completed due to the lot number being unknown.A trend review for the reported failure of disconnection and leak did not identify a trend.Three (3) used samples were received for evaluation.Visual inspection and functional testing performed confirmed the reported complaint of detached line from the cassette.The confirmed product failure is related to tubing diameter being out of specification, thus, tracing the cause to manufacturing.An investigation has been initiated to determine the root cause of this device failure and corrective actions have been implemented for the extrusion process of tubing line.Additional actions will not be taken at this time.This product issue will continue to be monitored and trended.

• 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: 11030494
• Report Number: 1282497-2020-09799
• Device Sequence Number: 2692522
• Product Code: LZH
• UDI-Device Identifier: 10884521190849
• UDI-Public: 10884521190849
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 03/02/2021
• Patient Sequence Number: 1