MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 12FR EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884715122E
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
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 when manipulating the patient, the gastrostomy tube was displaced.The balloon was tested with water, and it was found to be dysfunctional.A foley catheter was passed without resistance, and the balloon was insufflated.
Additional Manufacturer Narrative
H4 device manufacture date was added the device history record (dhr) review showed no discrepancy according to the failure mode reported.A sample analysis could not be performed because no photo or sample was available for evaluation.The complaint will be reopened if a sample is received.The reported condition could not be confirmed.Current process and controls were found to be followed correctly.However, due to similar cases reported in the past, a supplier corrective action was opened to address the reported condition through a more robust investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 12FR EN
• 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: 18702869
• Report Number: 9612030-2024-00037
• Device Sequence Number: 7217043
• Product Code: KNT
• UDI-Device Identifier: 10884521661622
• UDI-Public: 10884521661622
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 03/07/2024

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: 8884715122E
• Device Catalogue Number: 8884715122E
• Device Lot Number: 2227114864
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/07/2024
• Date Device Manufactured: 10/08/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown