MAUDE Adverse Event Report: CARDINAL HEALTH ENTRIFLEX 8FR 43IN W O STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720841E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/22/2024
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 the tube broke off at approximately15 cm, and the patient needed surgery to remove the piece.Additional information received: the broken tube was removed from the patient's stomach.It is unknown how the tube was removed because the patient was transferred to another hospital for the removal.
Additional Manufacturer Narrative
The device history record (dhr) for each possible lot number reported showed all inspections were carried out and within acceptable criteria as per established quality procedures.One sample was received and evaluated.A kind of ¿balloon¿ was observed at the tip of the tube, which caused it to rupture; however, the tip/weights were not received or evaluation.The reported condition was confirmed; however, the failure was not confirmed as originating at the manufacturing site.A walk through of the manufacturing process was performed showing all process and controls were found properly followed.The root cause could not be determined.The instructions for use (ifu) provide information for care of the device to prevent clogging.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRIFLEX 8FR 43IN W O STYLET
• 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: 19212376
• Report Number: 9612030-2024-00062
• Device Sequence Number: 8198697
• Product Code: KNT
• UDI-Device Identifier: 10884521582958
• UDI-Public: 10884521582958
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/03/2024

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: 8884720841E
• Device Catalogue Number: 8884720841E
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/03/2024
• 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