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

Model Number	8884721055E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Dyspnea (1816); Vomiting (2144)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported a burst tube.The tube was inserted on (b)(6) 2024.Additional information received on june 21, 2024, stated that the burst occurred near the 50cm marker on the tube, closer to the purple y port end.There were no pieces left in the patient, it appeared to have just ruptured but the entire tube was intact.The patient had respiratory distress, required suctioning (both orally and deep), vomited, and required oxygen by nasal canula.The patient did not require additional medical intervention to remove the tube, the tape securing the tube was removed and the tube was removed without issue.At this point the patient has recovered, a new tube was inserted, and ng feeds restarted.The patient required oxygen for approximately 48 hours.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because the lot number was not available.One sample was received for evaluation.The sample had a kind of coiled balloon near the number 50 of the tube.The damaged tube defect was confirmed.A walk through of the process was performed at the manufacturing site.All process and controls were found properly followed.The instructions for use (ifu) provides information on care of the feeding tube.The root cause could not be determined with the available information.Based on the assessment, no further actions are being pursued.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; 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: 19643307
• Report Number: 1423537-2024-00055
• Device Sequence Number: 15386988
• Product Code: KNT
• UDI-Device Identifier: 10884521582989
• UDI-Public: 10884521582989
• 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): 08/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884721055E
• Device Catalogue Number: 8884721055E
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown