MAUDE Adverse Event Report: CARDINAL HEALTH 14FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	7771410E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that after mmo (mucosal melanomas of the oral cavity) surgery, the surgeon placed a nasogastric tube (ngt) to suction/empty stomach for any blood or irrigation that might have went down the stomach.After suctioning, the resident took out the ngt and noticed that tip of the tube was missing.They did x-ray but unable to locate the tip.They had to go to ct scan, and they were able to locate where exactly the tip was, from there they went back to or and hn surgeon retrieved the missing part of the ngt.Additional information was received from the customer and stated that the patient is doing fine and recovered normally from the procedure.
Event or Problem Description
The customer reported that after mmo (mucosal melanomas of the oral cavity) surgery, the surgeon placed a nasogastric tube (ngt) to suction/empty stomach for any blood or irrigation that might have went down the stomach.After suctioning, the resident took out the ngt and noticed that tip of the tube was missing.They did x-ray but unable to locate the tip.They had to go to ct scan, and they were able to locate where exactly the tip was, from there they went back to or and hn surgeon retrieved the missing part of the ngt.Additional information was received from the customer and stated that the patient is doing fine and recovered normally from the procedure.The customer further stated that they do not have any additional information on how the missing part was retrieved.
Event or Problem Description
The customer reported that after mmo (mucosal melanomas of the oral cavity) surgery, the surgeon placed a nasogastric tube (ngt) to suction/empty stomach for any blood or irrigation that might have went down the stomach.After suctioning, the resident took out the ngt and noticed that tip of the tube was missing.They did x-ray but unable to locate the tip.They had to go to ct scan, and they were able to locate where exactly the tip was, from there they went back to or and hn surgeon retrieved the missing part of the ngt.Additional information was received from the customer and stated that the patient is doing fine and recovered normally from the procedure.The customer further stated that they do not have any additional information on how the missing part was retrieved.Additional information was received from the customer on 16-jan-2024 and stated that the tube indwelling was just for a few minutes to suck out the irrigation fluid and it was set to intermittent suction.The tube was not used to deliver any feeds or medications.The tube was only used for suction and no syringe was used.There was no resistance noted during tube removal.
Additional Manufacturer Narrative
The device history record (dhr) for reported lot number was reviewed indicating that the product was released accomplishing all quality standards.The device was received for evaluation and the reported condition has been confirmed.A corrective and preventive action has been initiated to address the reported.

• Brand Name: 14FR SALEM W/ GIENTRI PORT WIT
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 18337003
• Report Number: 9612030-2023-03880
• Device Sequence Number: 17820590
• Product Code: PIF
• UDI-Device Identifier: 10884521582729
• UDI-Public: 10884521582729
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7771410E
• Device Catalogue Number: 7771410E
• Device Lot Number: 2326838964
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 12/01/2023; 12/01/2023; 12/01/2023
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 12/20/2023; 01/17/2024; 02/22/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown