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

Model Number	461701
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the initial reporter, nursing claimed that the connector came apart from the feeding tube requiring the existing device to be removed and a new feeding tube placed.No patient injury.
Additional Manufacturer Narrative
The device history record file was reviewed indicating that product was released meeting all quality standard requirements.One sample was received for evaluation.A visual inspection was performed and the connector was found to be detached.The visual inspection confirms that the sample has solvent residue on the tube.The reported product is manufactured to withstand a pull force of up to 3.5 pounds; therefore, if a force greater than 3.5 pounds is applied between the purple connector and the tube, then the purple connector will detach from the tube.The presence of the bonding agent between the tube and the purple connector indicates that the feeding tube was assembled correctly.The potential root cause for the reported failure may be an exertion of force greater than 3.5 pounds on the connector.The current manufacturing process was reviewed and all product manufactured is meeting quality and manufacturing specifications.A corrective action is not deemed necessary 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: 7003634
• Report Number: 9612030-2017-05229
• Device Sequence Number: 13582803
• Product Code: KNT
• UDI-Device Identifier: 20884521067988
• UDI-Public: 20884521067988
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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: 07/01/2022
• Device Model Number: 461701
• Device Catalogue Number: 461701
• Device Lot Number: 1719121964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1