MAUDE Adverse Event Report: CARDINAL HEALTH 12 FR X 55 ENTRIFLEX W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721255
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the proximal site of the gastric tube y-port cracked easily and result in leakage during feeding.On 19sep2022 it was stated that normally user replaces the device every three months.For this incident, the user needed to replace the device after one month of usage.
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 indicated that the product was released accomplishing all quality standards.One photo was provided for evaluation.A cracked y-port was observed through the photo.However, signs of damage from mishandling could also be observed from the photo.An investigation was carried out with the multifunctional team.All processes and controls were found to be followed correctly, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.Please refer to the instructions for use (ifu) to avoid any blockage in the tube and leaking.Based on the available information, no action plan is required at this point.We will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.

• Brand Name: 12 FR X 55 ENTRIFLEX W/STYLET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west st; 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: 15471847
• Report Number: 9612030-2022-03400
• Device Sequence Number: 3050936
• Product Code: KNT
• UDI-Device Identifier: 10884521518926
• UDI-Public: 10884521518926
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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: 8884721255
• Device Catalogue Number: 8884721255
• Device Lot Number: 2019611464
• 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: 09/08/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/10/2022
• Date Device Manufactured: 07/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown