MAUDE Adverse Event Report: CARDINAL HEALTH POLYUR F T 6.5FRX20IN W ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461420E

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/17/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they were unable to flush or aspirate og.They removed the feeding tube to find it had a kink in it.They had to replace the tube.No patient injury or harm reported.

Manufacturer Narrative

The device history record (dhr) file for lot 2133600164 was reviewed and no discrepancies were found relating to the reported issue.The lot was released on 02dec2021.One sample without original packaging or lot number was received for evaluation.After performing a visual inspection per procedure, a mark between impression 8 and 9 was observed which resulting in a kinked/crooked tube.A gemba walk was carried out with the multifunctional team on the production line.The current process was running according to approved specifications.Based on the available information, a possible root cause could be poor placement resulting in a kinked tube.Please refer to the instructions for use (ifu) included with the product to review the insertion procedure.As an improvement, the work instructions were updated to include verification that the tube is not bent which will mitigate the risk of a tube being placed bent in the cavities and reaching the customer.No further actions are required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: POLYUR F T 6.5FRX20IN W ENFIT
• 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: 14459115
• MDR Text Key: 292214013
• Report Number: 9612030-2022-03259
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521547131
• UDI-Public: 10884521547131
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 461420E
• Device Catalogue Number: 461420E
• Device Lot Number: 2133600164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1