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.

Manufacturer Narrative

Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.However, a corrective and preventive action has been initiated to address the reported issue.

• 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
• UDI-Device Identifier: 10884521583023
• UDI-Public: 10884521583023
• 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,Followup
• Report Date: 05/28/2024

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?: No
• Device Model Number: 8884721237E
• Device Catalogue Number: 8884721237E
• Device Lot Number: 2306500264
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention