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

Model Number	ENFIT1000TC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, when a patient was receiving a feeding the rn noticed it was "leaking" and found the connector had "broken off inside the g-tube".The customer reported that a "kelly clamp" was used to remove the broken piece from the g-tube.The customer reported device was replaced and the procedure was able to be completed.The customer reported no serious injury or medical intervention/attention was required.Sample was requested to be returned.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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, when a patient was receiving a feeding the rn noticed it was "leaking" and found the connector had "broken off inside the g-tube".

• 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: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16682156
• Report Number: 1417592-2023-00153
• Device Sequence Number: 12804875
• Product Code: PIO
• UDI-Device Identifier: 10884389196915
• UDI-Public: 10884389196915
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/05/2023

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
• Operator of Device: Health Professional
• Device Model Number: ENFIT1000TC
• Device Catalogue Number: ENFIT1000TC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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