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

Model Number 7771810E

Device Problems Suction Problem (2170); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 211629944
• Report Number: 9612030-2020-02661
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521582743
• UDI-Public: 10884521582743
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other