MAUDE Adverse Event Report: CARDIANAL HEALTH ENTRFLX 8FR 43INW STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884720858

Device Problem Difficult to Remove (1528)

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

Event Type  malfunction  

Event Description

The customer reported after passage and examination confirming probe positioning, there was difficulty in removing the guide wire.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: h4 device manufacture date was added the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.A sample analysis could not be performed because no photo or sample was available for evaluation.The complaint will be reopened if a sample is received.Based on the present information a root cause cannot be determined.No action plan is required at this point.The manufacturing site will continue to monitor customer complaint and feedback notifications for adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

The device history record (dhr) was reviewed showing no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One sample was received for evaluation.The sample was functionally inspected.The hydromer was activated with approximately 10cc of water as stated in the instructions for use (ifu), and the stylet was able to be removed from the tube.The returned sample met specifications.The investigation was carried out with the multifunctional team.All processes and controls were found to be followed correctly.The ifu indicates, using a syringe, inject approximately 10 cc of water into the tube to activate the hydromer coating for the extraction of the stylet.Based on the analysis, no action plan is required.The manufacturing site will continue to monitor customer complaint and feedback notifications for adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 8FR 43INW STYLTY SITE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDIANAL 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: 16062663
• MDR Text Key: 308235640
• Report Number: 9612030-2022-03501
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884720858
• Device Catalogue Number: 8884720858
• Device Lot Number: 2025212864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1