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 Dyspnea (1816); Foreign Body In Patient (2687)

Event Date 03/14/2023

Event Type  Injury  

Event Description

The customer reported that the gravity head of the nasal feeding tube broke in the patient's esophagus in the department of general surgery of henan cancer hospital, which caused a great impact on the patient and department.The patient had shortness of breath after the tube was placed, and was immediately sent to scanning imaging.Later, the gravity head was found to have fallen in the airway, so it was taken out in time and observed.Per additional information provided on (b)(6) 2023, the weighted tip detached during the placement of the ng tube.On the afternoon of (b)(6) 2023, a ct scan of the patient's abdomen and chest was performed, looking for the tip of the weight until found, it was located in the patient's trachea.There were uncomfortable symptoms of respiratory distress during the period.The detached heavy tip was removed by using a tracheoscope clamp.A new ng tube was placed after the removal of the tip.The patient is in good condition currently.

Manufacturer Narrative

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

Manufacturer Narrative

Section h6 updated to include impact code 4627: device explantation.

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.Two photos and one physical sample were received for investigation.The photos and sample were evaluated, and the reported condition was confirmed.A corrective and preventative action has been initiated to further investigate and address the reported condition.This complaint will be used for tracking and trending purposes.

• 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 ; MX 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: 16586508
• MDR Text Key: 311736620
• Report Number: 9612030-2023-03648
• 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,Followup,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention