MAUDE Adverse Event Report: CARDINAL HEALTH 10FR X 55 ENTRIFLEX W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721055
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that they attempted the insertion of the feeding tube and were unable to pull the guidewire.Per additional information received on (b)(6) 2022, there was no medical intervention required.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.No physical samples or photos were received for the investigation.Because a sample was not received, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported condition and determine the root cause.A review of the manufacturing process was conducted and all processes and controls were found properly followed, including sub-assemblies, finished product assembly, and packaging.There were no abnormal conditions found that could trigger the reported condition.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.Current process controls are executed in accordance with product specifications to meet quality acceptance criteria.We will continue monitor the process, customer complaints, and feedback notifications for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: 10FR X 55 ENTRIFLEX W/STYLET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 14140879
• Report Number: 9612030-2022-03222
• Device Sequence Number: 19830103
• Product Code: KNT
• UDI-Device Identifier: 10884521518865
• UDI-Public: 10884521518865
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 8884721055
• Device Catalogue Number: 8884721055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown