MAUDE Adverse Event Report: COVIDIEN PORT GIENTRI 18FR SALEM SUMP; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number 7771810

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported the 18 fr stomach tubes are cracked/split at the end creating leaking tubes on the patient.

Manufacturer Narrative

A device history record review found no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.Six photos were submitted for evaluation two unused samples and four inserts with lot number 2028701764 were received for evaluation.The visual inspection was carried out according to procedure.Additionally, a functional test was carried out according to product specifications; when performing the leak test, it was observed that the connector that is attached to the salem tube was detached, which caused the leak.The reported condition is confirmed.The possible root cause was an improvement for the adhesive placement of the adapter.In order to mitigate the risk of detachment/leak the solvent application method was modified to include a specification that assures protruding tips of tube must be covered with solvent for better adherence.Pressure between both components and drying time was increased.Process and visual aids were added to update the application method and personnel were notified of the reported condition and the changes to be implemented.

• Brand Name: PORT GIENTRI 18FR SALEM SUMP
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12281548
• MDR Text Key: 265189204
• Report Number: 9612030-2021-03019
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 10884521004566
• UDI-Public: 10884521004566
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7771810
• Device Catalogue Number: 7771810
• Device Lot Number: 2028701764
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/29/2021
• Patient Sequence Number: 1