MAUDE Adverse Event Report: CARDINAL HEALTH 16FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	7771610E
Medical Device Problem Code	Fluid/Blood Leak (1250)
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 reported that the device was leaking at the connection between the ng tubing and the multifunction port connector.When the customer asked a large group of staff, they stated they have seen that but seems to be that someone put it in upside down or another instance it was not closed correctly on the dial.Per additional information received, they weren't pushing the multi-function port all the way into the tubing itself and therefore causing the leaks.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because the lot number of the device was not available.A sample analysis could not be performed because no photo or actual sample was available for evaluation.The complaint will be reopened if sample is received.The reported condition could not be confirmed.Based on the present information, and since no photo or actual sample was received; the reported condition could not be confirmed as related to the manufacturing process.No action plan could be performed.The current process controls are executed in accordance with product specifications to meet quality acceptance criteria.The manufacturing site will continue to monitor the process, customer complaints, and feedback notifications for any adverse trends that require immediate attention.In case of a repeated issue and/or recurrence, a new investigation for the specific events would be carried out for each case.This complaint will be used for tracking and trending purposes.

• Brand Name: 16FR 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: 13608304
• Report Number: 9612030-2022-03181
• Device Sequence Number: 5848533
• Product Code: PIF
• UDI-Device Identifier: 10884521582736
• UDI-Public: 10884521582736
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

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: 7771610E
• Device Catalogue Number: 7771610E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 02/26/2022
• Supplement Report FDA Received Date: 04/01/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown