MAUDE Adverse Event Report: CARDINAL HEALTH 14FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 7771410E

Device Problems Suction Problem (2170); Obstruction of Flow (2423)

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

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that they were having issues with the enfit getting clogged while using it on a patient for suction.They couldn¿t find any markings on the actual tube itself that said 14 fr and when they looked in their omnicells (in the hope they could find a normal salem sump), they stocked size was 18 fr.1a inserted the tube earlier in the day before he was upgraded, and the customer wondered if it was truly a 14 fr or they clicked the wrong size.They opened one of the 18 fr packages and changed the adapter to the one in that package on the off chance the adapter was also a bigger size, but it was not.The gastric content would flow through the 14 fr tube pretty easily it seemed.For a while we left the tube open onto a chuck pad just to let him drain while they troubleshooted.Even the chunky sludge drained from the open tube.They would manually hold the suction tubing to the end of his nasogastric tube (ngt) and it would pull contents.But the moment they re-attached the blue adaptor they would have trouble.For example, while they troubleshooted for an hour after bringing the patient to the floor, they would disconnect the adaptor and flush that piece out, reconnect and it would pull fluid freely until the sludge got backed up in the adapter and they would have to disconnect and flush it out again.Per customer, they got 1300ml out in that hour, but it required a nurse standing there the entire time to fiddle with the adaptor and flush it constantly or leave his drain open onto a chuck.There was no patient harm reported.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was not received for the investigation.Per customer, the sample was discarded.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 14FR SALEM W/ GIENTRI PORT WIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15816640
• MDR Text Key: 305519517
• Report Number: 9612030-2022-03470
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521582729
• UDI-Public: 10884521582729
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7771410E
• Device Catalogue Number: 7771410E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Male