MAUDE Adverse Event Report: CARDINAL HEALTH UNWTD KANG FEED TUBE 12FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884711501

Device Problem Complete Blockage (1094)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the nurse inserted a new feeding tube into the patient and fed via the main port but the side port was occluded as the nurse was unable to flush/aspirate from the side port.A new tube was opened and inserted into same patient and both ports were working well.No patient injury reported.

Manufacturer Narrative

A sample was not returned for evaluation.The device history record (dhr) file was reviewed, and no discrepancy was found according to the reported issue.The manufacturing process was reviewed.All processes and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.Furthermore since no samples or photos were returned, the reported issue could not be confirmed, and a possible root cause cannot be determined.If a sample is returned at a later date the investigation will be updated accordingly.Based on the available information, an action plan is not required at this time.The complaint will be used for tracking and trending purposes.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One sample was received for evaluation.After performing a visual inspection and a function test, an occlusion can be observed in the side port.A gemba walk was held with the cross-functional team on the production line.It was determined that the occlusion is caused by the assembly of the tube/port if the tube is pushed too far, occluding the side port.The production personnel received an awareness notification of this issue and the standard work instructions will be updated.This case will be used for tracking and trending purposes.

• Brand Name: UNWTD KANG FEED TUBE 12FR
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 15615910
• MDR Text Key: 306545536
• Report Number: 9612030-2022-03424
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521009684
• UDI-Public: 10884521009684
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8884711501
• Device Catalogue Number: 8884711501
• Device Lot Number: 1933040064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1