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 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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the tubing going into the cassette of the connect pump set got disconnected and leaked all over including the pump.There was no patient harm reported.
Additional Manufacturer Narrative
Additional information: h2, h3, h4, h6.Investigation summary: the customer reported the tubing going into the cassette of the connect pump disconnected and leaked all over including the pump.There was no patient harm reported.A device history record review of the reported lot number was unable to be completed as the lot number provided is invalid.Trend analysis was completed for the device failure and a trend was not identified.Three (3) used samples were returned for evaluation.Visual inspection and functional testing performed confirmed the line detached from the cassette.The root cause was identified as manufacturing related; the tubing diameter was not within specification which caused the detachment.An investigation for the extrusion process of tubing lines exists and corrective actions are underway/complete.No further action is required at this time and this confirmed 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: 10401237
• Report Number: 1282497-2020-09326
• Device Sequence Number: 14226572
• Product Code: LZH
• UDI-Device Identifier: 10884521190849
• UDI-Public: 10884521190849
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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
• Device Lot Number: 15682
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 03/01/2021
• Patient Sequence Number: 1