MAUDE Adverse Event Report: CARDINAL HEALTH 12 FR X 55 ENTRIFLEX W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721255
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Distress (2329); Foreign Body In Patient (2687)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on july 14, 2020.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.However, a corrective and preventative action has been initiated to address the reported condition.
Event or Problem Description
The customer reported that on (b)(6), in the 2nd department of general surgery of (b)(6) cancer hospital, an abnormality occurred after the patient was intubated, and the patient was immediately sent for x-ray confirmation.It was found that the gravity head of the nasal feeding tube was broken and fell into the patient's airway.The hospital immediately treated the patient.At present, the patient is in normal condition, but emotional.Per additional information provided on (b)(6), 2023 the weighted tip detached during the placement of the ng tube.The patient did not display any symptoms.The mention of the patient being intubated was in reference to the placement of the ng tube.The weighted tip was removed by surgical procedure.A new ng tube was then placed.

• Brand Name: 12 FR X 55 ENTRIFLEX W/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: 16638556
• Report Number: 9612030-2023-03657
• Device Sequence Number: 20170264
• Product Code: KNT
• UDI-Device Identifier: 10884521518926
• UDI-Public: 10884521518926
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/29/2023

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 Expiration Date: 06/30/2025
• Device Model Number: 8884721255
• Device Catalogue Number: 8884721255
• Device Lot Number: 2019611464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 03/29/2023
• Date Device Manufactured: 07/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown