MAUDE Adverse Event Report: COVIDIEN 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 Consequences Or Impact To Patient (2199)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that after the nurse pushed 20 cc of air into arv port before and after flushing, the nurse went to suction on the multifunction port salem sump and turned the dial in the direction of suction, as well as locking it in place, but still experienced leaking out of the feed/med port, even though the dial was positioned for suction and closed for feed/med.
Additional Manufacturer Narrative
The device history record was reviewed indicating that the product was released meeting all quality standard requirements.A sample outside of its original package and without a lot number was received for evaluation.After performing a functional inspection per product specifications, the reported condition was confirmed; leaking was observed into the valve anti reflux.During a walk through the assembly line the potential root cause for this condition is attributed to a mis-assembly of the umbrella in the port gentry during the manufacturing process.No corrective actions are deemed necessary at this time.The process is running according to product specifications meeting quality acceptance criteria and we will maintain continuous monitoring the process for any adverse trends that require immediate attention.

• Brand Name: 16FR SALEM W/ GIENTRI PORT WIT
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9191605
• Report Number: 9612030-2019-02321
• Device Sequence Number: 3731595
• Product Code: PIF
• UDI-Device Identifier: 10884521582736
• UDI-Public: 10884521582736
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

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
• Device Lot Number: 1920408464
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 01/02/2020
• Patient Sequence Number: 1