MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 18FR EN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	8884720189E
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/09/2024
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 hcas were providing morning care to resident and had just turned her onto her back when she held out her gt tube which was in her hand.Hcas immediately called writer who inserted a new gt tube without difficulty.Minimal bleeding noted at gt stoma.When they asked the resident how tube came out, she just shrugged.Resident denied any pain.Incident reported to manager as old tube was found to have hole in balloon and had just been inserted two days before.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event, and determined that: the returned sample device has a ruptured balloon.A supplier corrective action has been initiated to further investigate and address this issue.All information received will be used for further tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 18FR EN
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 19457962
• Report Number: 9612030-2024-00078
• Device Sequence Number: 6661362
• Product Code: PIF
• UDI-Device Identifier: 10884521661707
• UDI-Public: 10884521661707
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: 8884720189E
• Device Catalogue Number: 8884720189E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female