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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: the probe displacement was detected by the punctured balloon.
Additional Manufacturer Narrative
One gastro feed tube with y-port 20fr with an unknown lot number was received for evaluation.After performing a visual inspection and functional test in accordance to the test method for gastrostomy tube inflation system integrity, the reported condition was not confirmed on the received sample; the product complies with the specification according to acceptance criteria of manufacturing process.The samples received for evaluation does not present the reported condition.However, in order to determine a root cause, a gemba walk was done at the manufacturing facility focusing on the manufacturing equipment and process, however the root cause is undetermined.As a formal corrective/preventative action has been initiated to investigate and address the reported condition of a rupture and deflated balloon condition.
Additional Manufacturer Narrative
We have concluded our investigation process related to your complaint.Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further 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: 17503105
• Report Number: 9612030-2023-03785
• Device Sequence Number: 6513954
• 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,Followup
• Report Date (Section B): 02/05/2024

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: 2224233264
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 07/13/2023; 07/13/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 10/06/2023; 02/05/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown