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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
Benefis health system's icu reported that our salem sumps with multi-function port were leaking around the anti-reflux valve and in the seams of the multifunction port where the two sides of the front and back come together.It is noticed the most when reflux is seen coming up towards the arv and a buffer of air or liquid used to push it pack down via a syringe.Liquid fills the blue cavity and leaks out the seams of the device.
Additional Manufacturer Narrative
The device history record review could not be conducted because a lot number was not provided.There were no samples returned to the manufacturing site for evaluation however 2 photographs were received.The reported condition was not visible and could not be confirmed based solely on the photographs.A gemba walk through the manufacturing process was complete, in general, all process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging.There were no abnormal conditions found that could trigger the reported condition.The investigation did not identify a systemic issue or trend with the product or process therefore, a corrective and preventive action (capa) is not deemed necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• 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
• MDR Report Key: 12336727
• Report Number: 9612030-2021-03029
• Device Sequence Number: 19935240
• Product Code: PIF
• UDI-Device Identifier: 10884521582736
• UDI-Public: 10884521582736
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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
• Operator of Device: No Information
• Device Model Number: 7771610E
• Device Catalogue Number: 7771610E
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/08/2021
• Patient Sequence Number: 1