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

Model Number	8884720247
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the item is obstructed and another probe was placed.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed, and no discrepancy was found according to the failure mode reported.The device was manufactured on march 13, 2021.Sample analysis could not be performed as no photos or physical samples were received for evaluation.Current process and controls were reviewed and found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.Based on the present information, the reported complaint could not be confirmed, and the root cause could not be determined.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated to reflect our findings.No action plan is deemed required at this time.The current process is running according to product specifications meeting quality acceptance criteria.We will continue to monitor the process for any adverse trends that require immediate attention.

• Brand Name: GSTRO FEED TBE W/Y PRT 24FR
• 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: 15031951
• Report Number: 9612030-2022-03323
• Device Sequence Number: 12298996
• Product Code: KNT
• UDI-Device Identifier: 10884521007352
• UDI-Public: 10884521007352
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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: 2106127864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male