MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 20FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720205
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the device was put in on (b)(6) 2022 and on (b)(6) 2022 it was lost due to the device having a breakage in the balloon.No other information is able to be obtained as the event was reported anonymously.
Additional Manufacturer Narrative
Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A gemba walk was carried out with the multifunctional team on the production line.The current process was running according to approved specifications.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.The production personnel received an awareness notification of this issue.No further actions are required at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 20FR
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16264338
• Report Number: 9612030-2023-03540
• Device Sequence Number: 6053763
• Product Code: KNT
• UDI-Device Identifier: 10884521007291
• UDI-Public: 10884521007291
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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
• Device Model Number: 8884720205
• Device Catalogue Number: 8884720205
• Device Lot Number: 2119529964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/20/2023
• Date Device Manufactured: 07/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown