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

Model Number	7771810E
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Abdominal Distention (2601)
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: 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 or Problem 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.
Additional 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
• 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: 10906664
• Report Number: 9612030-2020-02701
• Device Sequence Number: 13741637
• 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): 02/01/2021

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: 7771810E
• Device Catalogue Number: 7771810E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 02/01/2021
• Patient Sequence Number: 1