MAUDE Adverse Event Report: CARDINAL HEALTH ENTFLX 12FR 43W OSTYL W Y PRT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721237E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the tip of feeding tube was left inside the patient when removed.Per additional information received, the tip was in the oropharynx.After imaging to confirm the presence of the tip, conscious sedation was administered to have it removed using surgical forceps.Injury was limited to the retention of the foreign object which was treated with surgical forceps.No further medical intervention was required.

• Brand Name: ENTFLX 12FR 43W OSTYL W Y PRT
• Type of Device: 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: 19015181
• MDR Text Key: 339058556
• Report Number: 9612030-2024-00053
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8884721237E
• Device Catalogue Number: 8884721237E
• Device Lot Number: 2306500264
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention