MAUDE Adverse Event Report: CARDINAL HEALTH DOBBHOFF 12FR 43IN W STYLET EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711253E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2023
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 reported when changing the enteral diet, leakage was noted in the infusion fitting of the y-port at the entrance of the nasoenteral tube.
Additional Manufacturer Narrative
Additional information: h4 device manufacture date was added the device history record (dhr) review showed that manufacturing and inspection of product was performed as per applicable procedures and validated processes.A sample evaluation could not be performed because no sample nor photo was provided for evaluation.The reported condition could not be confirmed.A corrective and preventative action has been initiated to address the reported issue.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed showing that manufacturing and inspection of product was performed as per applicable procedures and validated process.One sample was received for evaluation.The reported condition was confirmed.A corrective and preventive action has been initiated to address the reported issue.This complaint will be used for tracking and trending purposes.

• Brand Name: DOBBHOFF 12FR 43IN W STYLET EN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield 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: 17350372
• Report Number: 9612030-2023-03766
• Device Sequence Number: 5152354
• Product Code: KNT
• UDI-Device Identifier: 10884521582927
• UDI-Public: 10884521582927
• 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: 8884711253E
• Device Catalogue Number: 8884711253E
• Device Lot Number: 2007724964
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 07/10/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 09/07/2023; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown