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

Model Number 7771810E

Device Problem Suction Problem (2170)

Patient Problem Abdominal Distention (2601)

Event Type  malfunction  

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 Description

The customer reported: an ng was inserted into a patient and a 300 ml output occurred right away but then it stopped working.The multifunction port connection was changed and it began to work again but sluggishly.It has since stopped working and the patient woke up from sleep last night still very distended and uncomfortable.

Event Description

Additional information received stated the patient was experiencing a post-operative ileus.The enfit nasogastric tube (ng) was placed for decompression.Initial bleeding from the incision site occurred due to the patient gagging during ng placement, so it would appear the act of gagging was responsible for the initial dermabond site wound dehiscence.The area was cauterized with a silver nitrate stick by the md.The bleeding from the site continued into the following day however, because the patient continued to have nausea and vomiting after the tube was placed.Multiple imaging was done due to continued abdominal distention.Both xrays showed the tube was in the appropriate place in stomach.Imagining showed a post-operative ileus with some mild dilatation of the small bowel as well.

Manufacturer Narrative

Evaluation summary a review of the device history record (dhr) could not be conducted because a lot number was not provided.A picture was attached for evaluation; however, the reported condition could not be confirmed through the picture alone.Two decontaminated samples without their original package or lot number were received at the plant for evaluation.The sample was functionally tested according to the specification, but the reported condition of not suctioning was not confirmed.The samples passed the testing.No issues were found in the returned samples.As well, the samples were dimensioned in the specific section where the port is connected to the salem tube, and the results were found within specification.The length of the port was within specifications as well.It was observed that the tube of the received sample does not correspond to the reported product code in the complaint case.The returned product is a 14fr (product id 7771410e) and the reported code is for an 18 fr.After evaluation, the reported condition could not be confirmed.The product meets specifications.During the investigation, a review of the manufacturing process was conducted.All process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported conditions.No action plan is deemed required.The current process is running according to product specifications meeting quality acceptance criteria.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• 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: 10906664
• MDR Text Key: 218726892
• Report Number: 9612030-2020-02701
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7771810E
• Device Catalogue Number: 7771810E
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/24/2020
• Patient Sequence Number: 1