MAUDE Adverse Event Report: MITG - KENMEX KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711519
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 2017-09-08.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports the nurses experience leakage from the port cover while using it.Nurses had to secure tape to hold the port covers in place.
Additional Manufacturer Narrative
The device history record file was reviewed indicating that product was released meeting all quality standard requirements.A sample was received for evaluation.An evaluation was performed and there were no issues found.The reported issue could not be confirmed.Because the reported issue could not be confirmed, a root cause could not be determined.However, the dual port cap was found upside which will result in a weak seal and causing a leak.The dual port cap must be placed with the longest section sealing the dual port.A corrective action is not applicable at this time.This complaint will be used for tracking and trending purposes.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): MITG - KENMEX; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• MDR Report Key: 6851429
• Report Number: 9612030-2017-05159
• Device Sequence Number: 1117629
• Product Code: KNT
• UDI-Device Identifier: 20884521009698
• UDI-Public: 20884521009698
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 01/04/2018

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 Model Number: 8884711519
• Device Catalogue Number: 8884711519
• Device Lot Number: 627121564X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1