MAUDE Adverse Event Report: CARDINAL HEALTH KANG Y-SITE EXT SET ENFIT; PUMP, INFUSION, ENTERAL

Model Number	8884705008E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/23/2024
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
Customer reports: the y-site connector with enfit connection for the g/j tube broke.The enfit connector fell out of the y-site.The connector is supposed to be secured in place with glue from manufacturer.The patient receives total enteral nutrition (ten) overnight with insulin coverage prior.The insulin coverage administered per order and the ten started and later it was observed that the ten was leaking from the y-site.The patient with symptomatic hypoglycemia to 30's (diaphoretic).D50 was administered and the y-site replaced, and ten restarted.The provider was made aware.The blood glucose recovered; no further intervention was required.Per additional information received on (b)(6) 2024 the patient¿s 30¿s blood glucose level and subsequent treatment of administering the d50 was a result of the leaking/disconnected enfit connector.The patient is diabetic.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event, and determined that: the device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One product sample was provided by the customer.By examining the product, a disassembly was detected in connector y port.The root cause determined that the issue was related to manufacturing equipment; specifically, the lack of solvent from the dispenser.Equipment maintenance has been added to the work instructions.

• Brand Name: KANG Y-SITE EXT SET ENFIT
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; 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: 19454706
• Report Number: 9612030-2024-00076
• Device Sequence Number: 17914623
• Product Code: LZH
• UDI-Device Identifier: 30884521657612
• UDI-Public: 30884521657612
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/22/2024

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: 8884705008E
• Device Catalogue Number: 8884705008E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/22/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown