MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 22FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720221
Medical Device Problem Codes	Fluid/Blood Leak (1250); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the probe leaked after 24 hours of use.It was necessary to exchange the probe.Additional information received on 1/11/23 clarified that the probe refers to the balloon in this case.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A review of the device history record could not be conducted as the lot number was reported as unknown.A sample analysis was not possible as there was no photographs or samples provided for evaluation.Without a sample to evaluate, the reported conditions could not be confirmed; therefore, a possible root cause cannot be determined or related to a manufacturing process.During the investigation, a review of the manufacturing process was conducted.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging.There were no abnormal conditions found that could trigger the reported condition.Based on the limited information and lack of a sample to analyze, a corrective action plan is not required.The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: GSTRO FEED TBE W/Y PRT 22FR
• 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 ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16159665
• Report Number: 9612030-2023-03522
• Device Sequence Number: 20595984
• Product Code: KNT
• UDI-Device Identifier: 10884521007321
• UDI-Public: 10884521007321
• 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
• Report Date (Section B): 01/31/2023

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: 8884720221
• Device Catalogue Number: 8884720221
• Device Lot Number: 210263864
• 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: 01/06/2023
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 01/31/2023
• 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