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

Model Number	UNKNOWN ENTERAL ACCESS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation but did not provide rationale.
Event or Problem Description
Customer reports: a swedish icu experienced an interface cable failure during a placement which unfortunately resulted in the nurse causing a pneumothorax.The safety team is performing an investigation to confirm who's at fault and if the interface cable has been identified as the cause.Per additional information received from the customer on 10/24/23, the clinical attempted to use the iris feeding tube, however prior to placement, there was no signal on the camera and the device could not be used.The customer stated they believe it was an issue with the interface cable.The clinician used another feeding tube and placed the device blindly which caused the pneumothorax.The clinician did not know if the feeding tube used was a cardinal health device.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.
Additional Manufacturer Narrative
Based on the additional information provided by the customer on 10/25/23, the clinician was unsure if the feeding tube that was used was a cardinal health device therefore the following fields were corrected: section d1: brand name - initially reported as iris interface cable has been updated to unknown enteral access feeding tube.Section d4: model number - initially reported as product code 388103 has been updated to unknown enteral access.Section d4: catalog number - initially reported as product code 388103 has been updated to unknown enteral access.Section d4: unique identifier - initially reported as (udi) #(b)(4) should be blank.

• Brand Name: UNKNOWN ENTERAL ACCESS FEEDING TUBE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18006979
• Report Number: 1282497-2023-10801
• Device Sequence Number: 7593318
• Product Code: KNT
• UDI-Device Identifier: 10884521165014
• UDI-Public: 10884521165014
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2023

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?: No
• Device Model Number: UNKNOWN ENTERAL ACCESS
• Device Catalogue Number: UNKNOWN ENTERAL ACCESS
• 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: 10/02/2023
• Supplement Date Received by Manufacturer: 10/02/2023; 10/02/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 11/01/2023; 11/09/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown