MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; DBD-ENFIT G-TUBE CONNECTOR,MEDLINE

Catalog Number	ENFIT1010GC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported, "enfit g-tube connector with hard plastic insert piece within silicone connector dislodge and retained in gastrotomy or jejunostomy tubes for (2) patients.In both cases, these pieces needed to be removed with kelly clamps." 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
Customer reported, "enfit g-tube connector with hard plastic insert piece within silicone connector dislodge and retained in gastrotomy or jejunostomy tubes for (2) patients.In both cases, these pieces needed to be removed with kelly clamps.".

• Brand Name: MEDLINE
• Common Device Name: DBD-ENFIT G-TUBE CONNECTOR,MEDLINE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: brooke jantzen ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24945470
• Report Number: 1417592-2026-00509
• Device Sequence Number: 5406120
• Product Code: PIO
• UDI-Device Identifier: 40888277314710
• UDI-Public: 40888277314710
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K151628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2025
• Device Catalogue Number: ENFIT1010GC
• Device Lot Number: 96922110001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-26-012
• Patient Sequence Number: 1
• Patient Sex: Unknown