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

Model Number 8884721255

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Distress (2329); Foreign Body In Patient (2687)

Event Date 03/14/2023

Event Type  Injury  

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 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
• 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: 16638556
• MDR Text Key: 312259686
• Report Number: 9612030-2023-03657
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518926
• UDI-Public: 10884521518926
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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 Model Number: 8884721255
• Device Catalogue Number: 8884721255
• Device Lot Number: 2019611464
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/29/2023
• Date Device Manufactured: 07/14/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1