MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 10FR 43IN W STY YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721088E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the tube broke during patient care in the icu.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because no lot number was provided.No samples or photos were received for evaluation.The reported condition could not be confirmed.A walk through of the process was performed, and all process and controls were found properly followed.Based on the historical review, a corrective and preventative action (capa) was opened to further investigate the issue as the assembly operation is manually performed by production personnel.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 10FR 43IN W STY YPORT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19527665
• Report Number: 1423537-2024-00036
• Device Sequence Number: 18068538
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: 10884521582996
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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: 8884721088E
• Device Catalogue Number: 8884721088E
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 06/19/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown