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

Model Number	ENFIT1000TC
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2022 the 'transition connector broke off in the patient's peg tube after a feeding cycle'.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 the 'transition connector broke off in the patients peg tube after a feeding cycle'.Per the facility the issue was noticed when 'pulling away from the tube, leading the connector to break off in the j-tube'.Per the facility they believe 'some of the purple pieces probably went through the gi tract but did not require further intervention'.The patient is reporting to being doing well.The device was returned for evaluation, however, a definitive root cause could not be determined at this time.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.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.

• Brand Name: Medline
• Common Device Name: ENFIT SET TRANSITION CONNECTOR, MEDL
• 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: 16086799
• Report Number: 1417592-2023-00002
• Device Sequence Number: 6733935
• Product Code: PIO
• UDI-Device Identifier: 10884389196915
• UDI-Public: 10884389196915
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 01/03/2023

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: ENFIT1000TCH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 01/03/2023
• 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: Required Intervention
• Patient Sex: Unknown