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

Model Number 8884721252E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/19/2022

Event Type  Injury  

Event Description

The customer reported that the distal end of the catheter has become detached.This tube was inserted in an anaesthetized patient (in intensive care).The intubation probe was positioned in the trachea instead of the esophagus.Following the observation of the positioning, during removal, the distal end of the probe was no longer present via imaging check.After observation (syringe test) and during removal, the distal end was "pinched" between the balloon of the intubation probe and the tracheal wall.The disconnect occurred at this time.The distal end migrated toward the stem bronchus of the lower lobe of the left lung and was removed via fibroscopy.There were no clinical consequences for this patient.

Manufacturer Narrative

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

Manufacturer Narrative

A sample was 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 or determine a root cause.However, a corrective and preventive action has been initiated to further address the reported issue.

• Brand Name: ENTRFLX 12FR 43IN W STYL YPOR
• 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: 16163309
• MDR Text Key: 307465042
• Report Number: 9612030-2023-03524
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521583030
• UDI-Public: 10884521583030
• Combination Product (y/n): N
• Reporter Country Code: RE
• 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
• Report Date: 02/08/2023

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: 8884721252E
• Device Catalogue Number: 8884721252E
• Device Lot Number: 2132808764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 02/08/2023
• Date Device Manufactured: 11/24/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other