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

Model Number	8884720817E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the ng tube appeared cracked at the purple y connection and was leaking.The ng tube was taped and left insitu in patient as the patient required a general anesthetic for insertion.
Event or Problem Description
The customer reported that the ng tube appeared cracked at the purple y connection and was leaking.The break was in a very unusual spot.The ng tube was taped and left insitu in patient as the patient required a general anesthetic for insertion.Sample was discarded once replaced.
Additional Manufacturer Narrative
Describe event or problem was updated with more information.Date of event was changed to (b)(6) 2018.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: 7853030
• Report Number: 9612030-2018-00148
• Device Sequence Number: 13844301
• Product Code: KNT
• UDI-Device Identifier: 10884521582934
• UDI-Public: 10884521582934
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/25/2018

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: 11/01/2022
• Device Model Number: 8884720817E
• Device Catalogue Number: 8884720817E
• Device Lot Number: 1731181764
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1