MAUDE Adverse Event Report: CARDINAL HEALTH UNKNOWN ENTERAL ACCESS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721088E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Event Description

The customer reported they had a placement with a 12fr/43in tubes in the previous week that was confirmed with pneumothorax but no death or other harm occurred.They made the decision to pull the 12fr tubes from the floors thinking it could be a product issue.Per additional information received, there was no difficulty inserting the device.The sequence of events are as a follows: the feeding tube was placed and an xray was obtained to verify placement and a pneumothorax was noted.There was no clinical decompensation.A chest tube was placed.The patient was discharged on (b)(6).

Manufacturer Narrative

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

Manufacturer Narrative

Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.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 and determine the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

Corrected section h1/h2 type of reportable event: from: death.To: serious injury.Corrected section h6 type of investigation: from: 3331 and 4114.To: 4114.

• Brand Name: UNKNOWN ENTERAL ACCESS
• 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: 18178990
• MDR Text Key: 328620992
• Report Number: 9612030-2023-03866
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: 10884521582996
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2024

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?: No
• Device Model Number: 8884721088E
• Device Catalogue Number: 8884721088E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 10/26/2023; 10/26/2023
• Supplement Dates FDA Received: 02/08/2024; 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention