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

Model Number	8884720205
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Codes	Vomiting (2144); Skin Inflammation/ Irritation (4545)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
It was reported to anvisa anonymously that the cuff is much larger in size than other tubes.In one specific case with general atrophy, it generated vomiting due to high volume of water from the cuff (20ml) with migration from the cuff to the duodenum.Frequent cuff rupture with probe in less than 60 days of use.Difficult connection with diet equipment.Frequent skin reaction with the ostio.Bad seal on the probe covers.Host leak.No additional information can be requested as the initial reporter is unknown.
Additional Manufacturer Narrative
A sample was not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.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 the root cause, therefore a corrective action is not applicable 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: 18481033
• Report Number: 9612030-2024-00009
• Device Sequence Number: 6426559
• Product Code: KNT
• UDI-Device Identifier: 10884521007291
• UDI-Public: 10884521007291
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: 2223111364
• 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: 12/22/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/06/2024
• Date Device Manufactured: 09/04/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown