MAUDE Adverse Event Report: CARDINAL HEALTH 16FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 7771610E

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

Patient Problems Pain (1994); Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that there were multiple concerns escalated related to the clogging of the enfit ng tube.Per customer, most recently it caused patient¿s discomfort and potential harm with clog causing 1200 ml of contents not being extracted.As a staff work around, an alternate connector from different/previous product was used.Additional information was received and stated that specific concern reported was that the contents from the stomach were thick/chunky and tube continued to clog although flushing was occurring.Multi-functioning connecter was removed and replaced with a different (previous) connection that allowed the contents to drain/empty so the patient could have symptom relief and the result was the 1200 ml of content was extracted after the connector was changed.Then the connection piece was replaced back with the multi-function one.There was no harm just a concern for pain/discomfort due to contents not draining appropriately.

Manufacturer Narrative

Since a lot number was not provided, the device history record review could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A physical sample was not received for the investigation.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.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: 16FR SALEM W/ GIENTRI PORT WIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 14190125
• MDR Text Key: 290792095
• Report Number: 9612030-2022-03230
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521582736
• UDI-Public: 10884521582736
• 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: 06/03/2022

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
• Device Model Number: 7771610E
• Device Catalogue Number: 7771610E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 06/03/2022
• 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