MAUDE Adverse Event Report: CARDINAL HEALTH UNKNOWN ENTERAL FEEDING; PUMP, INFUSION, ENTERAL

Model Number UNKNOWN ENTERAL FEEDING

Device Problem Air/Gas in Device (4062)

Patient Problems Vomiting (2144); Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that a pediatric patient, under the care of the reporter, experienced vomiting and severe discomfort on several occasions following air becoming trapped in the line of the joey feeding sets.

Manufacturer Narrative

The device history record (dhr) could not be reviewed because a lot number was not available.No sample was returned for evaluation.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition.If a sample should be returned later, this complaint will be reopened and the investigation updated to reflect our findings.A video was provided, and the manufacturing site could confirm the reported condition from this review.The manufacturing site is aware of this issue through other complaints received, and a corrective and preventative action (capa) has been opened to further investigate this issue.This complaint will be used for tracking and trending purposes.

• Brand Name: UNKNOWN ENTERAL FEEDING
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18192443
• MDR Text Key: 328809405
• Report Number: 9611018-2023-00634
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN ENTERAL FEEDING
• Device Catalogue Number: UNKNOWN ENTERAL FEEDING
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2023
• Type of Device Usage: A
• Patient Sequence Number: 1