MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 12FR 43IN W STYL YPOR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721252E
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported it was difficult, even impossible to remove the guide, even after lubricating the tube and insertion.The product was checked before use and it was adequate.They tried another tube and had the same problem.There was trauma for the beneficiary.Per additional information provided on october 19, 2022 there was no physical trauma but rather psychological trauma related to the repeated attempts to withdraw the guide wire from the tube as well as the back and forth movements of the tube in the nasal wall, the throat, and in the esophagus during attempts to withdraw the guide with the associated risks.The tube was finally removed and another tube was installed with the same difficulties.To their knowledge there has been no medical treatment/intervention.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on december 20, 2021.The investigation was carried out with the multifunctional team.A gemba walk was performed, and all processes and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.No abnormal conditions were found that could trigger the reported condition.One sample was received at the manufacturing site and evaluated; the hydromer was activated according to the instructions for use for 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¿.The reported condition could not be confirmed, the stylet was extracted from the tube and the product was confirmed to meet specifications.A corrective action is not applicable at this time.We will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 12FR 43IN W STYL YPOR
• Common Device Name: 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: 15639687
• Report Number: 9612030-2022-03432
• Device Sequence Number: 6377390
• Product Code: KNT
• UDI-Device Identifier: 10884521583030
• UDI-Public: 10884521583030
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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: 8884721252E
• Device Catalogue Number: 8884721252E
• Device Lot Number: 2134806464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown