MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; ENFIT SET TRANSITION CONNECTOR, MEDLINE

Model Number	ENFIT1000TC
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Feeding Problem (1850)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2022, the patient's mother disconnected the feeding after a cycle and when she was going to start the next feeding cycle she noted an 'occlusion in the tube' that appeared to be 'part of the adaptor'.According to the customer the patient was taken to the hospital where he had a procedure with interventional radiology to have the tube replaced.According to the customer the mother reported that her son tolerated the procedure and denies any injury.The sample was returned for evaluation and a definitive root cause could not be determined at this time.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on (b)(6) 2022, the patient's mother disconnected the feeding after a cycle and when she was going to start the next feeding cycle she noted an 'occlusion in the tube' that appeared to be 'part of the adaptor'.

• Brand Name: Medline
• Common Device Name: ENFIT SET TRANSITION CONNECTOR, MEDLINE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15821305
• Report Number: 1417592-2022-00223
• Device Sequence Number: 6143284
• Product Code: PIO
• UDI-Device Identifier: 10884389196915
• UDI-Public: 10884389196915
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: ENFIT1000TC
• Device Catalogue Number: ENFIT1000TC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown