MAUDE Adverse Event Report: CARDINAL HEALTH DOBHFF 8FR 43IN W STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884710859

Device Problem Difficult to Remove (1528)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the guide wire was stuck inside the lumen of the tube.Additional information was received and stated that a new device was replaced for the patient that they had on the shelf.There was no harm reported.

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on 12-july-2022.One decontaminated sample was received for the evaluation.The sample was visually inspected, and the test was carried out to activate the hydromer in the tube according to the instructions, the reported issue was not confirmed, the hydromer was activated, and the stylet was withdrawn without problem.Please refer to the ifu (instructions for use) for the proper procedure for insertion of the feed tube and extraction of the stylet: "using a syringe, inject approximately 10 cc of water into the tube to activate the hydromer coating".At this time, a corrective and preventative action (capa) 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: DOBHFF 8FR 43IN W STYLTY SITE
• 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: 16404798
• MDR Text Key: 309953553
• Report Number: 9612030-2023-03554
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518766
• UDI-Public: 10884521518766
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8884710859
• Device Catalogue Number: 8884710859
• Device Lot Number: 2219308964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1