MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 24FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720247
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the patient exchanged the device on (b)(6), 2023 and observed that the balloon was punctured.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Additional information: h4 device manufacture date added the device history record (dhr) was reviewed showing no discrepancies.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.A walkthrough was performed of the manufacturing process.Current process and controls were found to be followed correctly.A supplier corrective action (scar) was opened to the supplier to address the reported condition through a more robust investigation.Results of the investigation will be documented through a corrective and preventative action (capa).This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed showing no discrepancy.One feeding tube was received for evaluation.Visual inspection showed a rupture in the balloon.The reported condition was confirmed.A walk through was carried out of the manufacturing process.Current process and controls were found to be followed correctly.Based on the historical review, a supplier corrective action was opened to address the reported condition through a more robust investigation.The results of the investigation will be documented through the referred corrective and preventative action (capa).This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 24FR
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfiedl 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: 17305717
• Report Number: 9612030-2023-03757
• Device Sequence Number: 15233904
• Product Code: KNT
• UDI-Device Identifier: 10884521007352
• UDI-Public: 10884521007352
• 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): 11/28/2023

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: 8884720247
• Device Catalogue Number: 8884720247
• Device Lot Number: 2213733764
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 07/03/2023; 07/03/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/15/2023; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown