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

Model Number	7771610E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
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.
Event or Problem Description
The customer reported that the nurse was checking the device for patency during use using air bolus and determined that it would not bolus air.All troubleshooting was performed.After testing with and without the port attached, the issue seemed to be with the port.There was no patient injury.Additional information provided on (b)(6) 2021 stated that the customer was trying to push air through the feed/med only purple port to check for any blockages.The customer confirmed that they did have the dial turned to the correct port but they were unable to bolus any air.The customer then removed the entire multifunctional port and pushed air through the tubing with a syringe which worked fine.For this reason, the customer feels that there is some sort of blockage in the multifunctional port.
Additional Manufacturer Narrative
A review of the device history record showed no abnormal process conditions were present during the manufacturing of the product that could have led to the defect described by the customer.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were four decontaminated sample with multiple lot numbers.A visual and functional inspection was performed as per procedure.Sample a: there were no issues found for lot #2013302164 (port enfit 2008419164s) and the issue reported could not be confirmed based on this sample.Sample b: there were no issues found for lot 2021002364 (salem sump 2010529164s and port enfit2017601764s) and the issue reported could not be confirmed based on this sample.As for sample c+d two salem sump, lot# 2017601764s, the reported condition was confirmed; the purple adapter was occluded and did not meet product specifications.An investigation was conducted by a multifunctional team.Manufacturing process was reviewed.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition; as well, there have been no similar cases detected in the manufacturing process for this condition in the past.The most likely root cause is due to a workmanship issue by applying excess solvent to the product, which caused the adapter input to be covered.He reported condition of an occlusion was evaluated against the acceptable quality limit (aql), and no action plan is deemed required since the complaint reported represents a rate of (b)(4)% which is below the aql of (b)(4) %.We will continue 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: 11777208
• Report Number: 9612030-2021-02885
• Device Sequence Number: 14237409
• Product Code: PIF
• UDI-Device Identifier: 10884521582736
• UDI-Public: 10884521582736
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/21/2021
• Patient Sequence Number: 1