MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 12FR 43IN W STYL YPOR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721252E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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 when the probe was inserted, the weighted tip came loose.The tip remained in the patient's sinus with no possibility of removal at the time.
Additional Manufacturer Narrative
H4 device manufacture date was added.The device history record (dhr) review showed that manufacturing and inspection of the product was performed as per applicable procedures and validated process.Photos were provided showing the weighted tip was detached from the feeding tube.No sample was received for evaluation.The reported condition was confirmed through the photos.A walk through was performed of the manufacturing process and all process and controls were found properly followed.The exact root cause could not be determined with the available information.Based on the historical review, a corrective and preventative action (capa) was generated to further investigate the reported condition.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 12FR 43IN W STYL YPOR
• 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: 18484211
• Report Number: 9612030-2024-00011
• Device Sequence Number: 2820658
• Product Code: KNT
• UDI-Device Identifier: 10884521583030
• UDI-Public: 10884521583030
• Combination Product (Y/N): N
• 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): 03/12/2024

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: 8884721252E
• Device Catalogue Number: 8884721252E
• Device Lot Number: 2300301164
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 03/12/2024
• Date Device Manufactured: 03/01/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown