MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 16FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720163E
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 reports that in the days following the replacement of the peg, there is wear of the outer button with leakage of gastric material and rupture of the peg.This type of non-serious accident occurs frequently in other patients with the use of the same device with different lots.
Event or Problem Description
Additional information received: there was a rupture of the balloon and the y port.The device was replaced.This has happened other times but how many times and when it happened is unknown.
Additional Manufacturer Narrative
Additional information: the device history record (dhr) was reviewed showing the reported lot number corresponds to product 8884720163e, not the code reported by the customer as 8884720163.The dhr showed no discrepancy.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.Based on the present information, a possible root cause cannot be determined.No action plan is deemed required.The current process is running according to product specifications, meeting quality acceptance criteria.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.Production personnel received an awareness notification regarding the reported condition.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Corrected: d4 the model number and catalog number was corrected because the device history record review showed the reported lot number corresponds with 8884720163e, not 8884720163.

• Brand Name: GSTRO FEED TBE W/Y PRT 16FR
• 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: 16085733
• Report Number: 9612030-2023-03505
• Device Sequence Number: 11267617
• Product Code: KNT
• UDI-Device Identifier: 10884521007260
• UDI-Public: 10884521007260
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 02/02/2023

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: 8884720163E
• Device Catalogue Number: 8884720163E
• Device Lot Number: 2130035964
• 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: 12/20/2022
• Supplement Date Received by Manufacturer: 12/20/2022; 12/20/2022; 12/20/2022
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/09/2023; 02/01/2023; 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown