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

Model Number	8884721252
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2022
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 the guide wire gets "stuck" and will not come out unless force is used.It was confirmed that they inserted per the instructions and also flushed the tube with water to help it slide out as recommended.Also, the cap is coming off the guidewire and poking staff.Additional information received stated the customer knows of at least two times that a staff member got stuck from the guidewire.No medical intervention was required.Several staff members have reported the guide wire got stuck and the cap came off but they didn't report it at the time.They don't know the lot number because these were all in the past.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because no lot number was available.A sample evaluation could not be performed because no sample nor photo was provided.The reported condition could not be confirmed.The root cause could not be identified.A walk through of the process was carried out.Current process 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.No action plan is required at this point.The manufacturing site will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.

• Brand Name: ENTFLX 12FR 43IN W STYL YPORT
• 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: 15519545
• Report Number: 9612030-2022-03405
• Device Sequence Number: 6056130
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: 10884521518919
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/28/2022

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: 8884721252
• Device Catalogue Number: 8884721252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 10/28/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown