MAUDE Adverse Event Report: COVIDIEN KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720221
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states that they inserted the g tube on (b)(6) 2017 and it started to leak on (b)(6) 2017.There was no injury to the patient.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was release accomplishing all quality standards.A decontaminated sample without original packaging or lot number was received at the plant for the investigation.Upon a visual evaluation of the sample, the defect was confirmed; the tubing was detached from the inlet port.After performing a visual inspection based on current procedures, leaks were observed in the balloon.Since this catheter is a purchased component from an outside supplier a complaint notification and the sample were sent to the supplier to initiate the investigation into the root cause.Per the supplier, while the balloon burst was confirmed, the exact root cause remains undetermined.Possible factors that affect product performance include device handling, packaging, shipping, storage, cleaning, over-inflation, the liquid used to inflate the balloon of the device, and maintenance.Additional possibilities that affect balloon life include unique patient factors such as diagnosis, treatment, surgical procedures, as well as medications, nutrition formulas, and gastric ph.Some patients also ingest food orally when the device is still in place which could also impact the balloon performance of the device.Per the supplier, their current controls include training and certification of all production personnel and qc inspectors.Line clearances are performed and documented at each work station.All molds, presses, and testing equipment used to manufacture the product line are documented within device history records, and cleaned and calibrated when applicable.Controls surrounding the actual silicone material used include stringent storage, milling, cleaning, and extrusion rules.Detailed dhr/pic (pictorial instructions) are present at each work station and deliver specific guidance for every step of the manufacturing process.To mitigate the risk of releasing devices with potential leaks, every device is air tested during manufacturing where the feeding, medication, and inflation lumens are tested for plugs and/or leaks.Also, every unit is 100% functionally tested during the process, where it is inflated for a minimum of 10 minutes and inspected visually prior to accepting the unit for distribution.This complaint will be used for qa tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states that they inserted the g tube on (b)(6) 2017 and it started to leak on (b)(6) 2017.There was no injury to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• MDR Report Key: 7163446
• Report Number: 9612030-2018-00001
• Device Sequence Number: 11209178
• Product Code: KNT
• UDI-Device Identifier: 20884521007328
• UDI-Public: 20884521007328
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Followup
• Report Date (Section B): 10/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 8884720221
• Device Catalogue Number: 8884720221
• Device Lot Number: 1719118864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Received by Manufacturer: 12/16/2017
• Supplement Date Received by Manufacturer: 12/16/2017; 08/08/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 07/24/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1