MAUDE Adverse Event Report: COVIDIEN 18FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	7771810E
Medical Device Problem Codes	Suction Problem (2170); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Appropriate term/code not available: the patient required sicu admission, intubation, antibiotics, and tracheostomy for prolonged intubation.An investigation is currently underway, the results will be shared upon completion.
Event or Problem Description
The customer reported that the patient's ng was not suctioning.It is currently working, but per the nurse, not as it should.Also, when changing the multiport device, the connection site broke.Additional information provided by the customer stated that there was an injury associated with this event.The patient required sicu admission, intubation, antibiotics, and tracheostomy for prolonged intubation.The nurse further stated that she felt that the suctioning was not as strong as it should have been, it was lackluster or mediocre.
Additional Manufacturer Narrative
A device history record (dhr) review could not be performed because a lot number was not provided.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One decontaminated gientri port without the original package or lot number was received for evaluation.The returned device was functionally tested according to the specifications.The reported condition of the ng not suctioning was not confirmed; the sample passed the testing, and no issues were found.The dimensions of the device in the specific section where the port is assembled with the salem tube was also checked.The results were determined to be within specification as well as the length of the port.The reported issue regarding a broken connector was observed and confirmed on the returned device.This failure could not be replicated under normal conditions of use, however, based on additional experimentations performed to these products, it was observed that the connector can break by applying excessive force when removing the syringe from the adapter.A review through the manufacturing process was conducted.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 conditions.Based on the results of the investigation performed, the reported issues could not be confirmed to be generated by the manufacturing process.A corrective action is not applicable at this time as the current process is running according to product specifications and meeting quality acceptance criteria.We will continue to monitor the process for any adverse trends that require immediate attention.

• Brand Name: 18FR 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: 10687211
• Report Number: 9612030-2020-02661
• Device Sequence Number: 18975619
• Product Code: PIF
• UDI-Device Identifier: 10884521582743
• UDI-Public: 10884521582743
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 7771810E
• Device Catalogue Number: 7771810E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other