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

Model Number	8884752067
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 4/11/2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states that while prepping the peg, the guide wire ruptured and detached from the tube causing it to partially perforate the gastric wall and was in the stomach cavity.They needed to restart with a new tube and due to the imminent risk of the bleeding and pneumo-peritoneum, the patient¿s hospital stay was extended.There was no patient injury as a result of the event.
Additional Manufacturer Narrative
Submission date: (b)(6) 2018 an investigation was performed for the reported customer complaint: ¿the customer states that while prepping the peg, the guide wire ruptured and detached from the tube causing it to partially perforate the gastric wall and was in the stomach cavity.They needed to restart with a new tube and due to the imminent risk of the bleeding and pneumo-peritoneum, the patient¿s hospital stay was extended.There was no patient injury as a result of the event.¿ a review of the device history record (dhr) for lot no.614585064x indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.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): COVIDIEN; calle 9 sur no. 125; cuidad industrials; tijuana,na 22444 ; MX 22444
• MDR Report Key: 7421618
• Report Number: 9612030-2018-00053
• Device Sequence Number: 39254
• Product Code: KNT
• UDI-Device Identifier: 10884521070059
• UDI-Public: 10884521070059
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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: 06/30/2021
• Device Model Number: 8884752067
• Device Catalogue Number: 8884752067
• Device Lot Number: 614585064X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR