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

Model Number	8884720858
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
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that a 8fr nasojejunal tube was passed to the patient and when trying to use it, occlusion was detected.The tube was withdrawn and its kinking was observed (with memory).A new probe was passed.
Additional Manufacturer Narrative
A photo sample was received at the plant for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual evaluation of the photo sample, the reported was unconfirmed.Because a physical sample was not returned, we were unable to perform a follow up investigation to include functional evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.If a physical sample is received at a later date, this complaint will be reopened for further investigation.

• Brand Name: ENTRFLX 8FR 43INW STYLTY SITE
• 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: 17321026
• Report Number: 9612030-2023-03758
• Device Sequence Number: 17764470
• Product Code: KNT
• UDI-Device Identifier: 10884521518858
• UDI-Public: 10884521518858
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 08/22/2023

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: 8884720858
• Device Catalogue Number: 8884720858
• Device Lot Number: 2028702764
• 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: 06/23/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown