MAUDE Adverse Event Report: CARDINAL HEALTH POLYUR F T 5FRX36IN W ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461503E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that they have seen an increase in nec (necrotizing enterocolitis) in the nicu.They have been exploring multiple avenues to assess what could be contributing to this.After working with infection prevention and obtaining cultures on multiple patients, they have determined that the findings are concerning with the possibility of bacteria being introduced to their babies through the enteral feeding tubes via the moat.They have tried multiple routes to clean the feeding tubes - the two different bristle brushes and the toothbrush (see attachment), did not seem to clean the 'moat' of the tubes thoroughly.The suggestion on the attached cleaning practices was to clean the moat once a shift.So, they came up with their own practice to flush the tubes with 1cc sterile water and then rinse the moat with 2cc of sterile water after each feed and tap the moat onto a sterile gauze.The cultures were obtained after this cleaning practice was initiated and they still have these results after culture.Per additional information received, the tubes that were tested had been used.They did not visibly see signs of the bacteria or any foreign substance in the moat of the tube.The customer was unable to provide any further information.
Additional 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.

• Brand Name: POLYUR F T 5FRX36IN W ENFIT
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 17650217
• Report Number: 9612030-2023-03817
• Device Sequence Number: 17987075
• Product Code: PIF
• UDI-Device Identifier: 10884521547155
• UDI-Public: 10884521547155
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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: 461503E
• Device Catalogue Number: 461503E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown