MAUDE Adverse Event Report: BETA BIONICS INC. INSET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	FG000016-05
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 8021545, manufacturing site: 3003442380.
Event or Problem Description
It was reported that the patient accidentally ripped off the infusion sets on (b)(6) 2026 after the tubing caught on the door frames causing the adhesive to be removed.The event occurred with about eight different sets over three boxes.

• Brand Name: INSET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BETA BIONICS INC.; 8 saint mary¿s street; suite 936; boston MA 02215
• Manufacturer (Section G): BETA BIONICS INC.; 8 saint mary¿s street; suite 936; boston MA 02215
• Manufacturer Contact: courtney smith ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; 6032470255
• MDR Report Key: 24786692
• Report Number: 3003442380-2026-88608
• Device Sequence Number: 12295507
• Product Code: FPA
• UDI-Device Identifier: 05705244026254
• UDI-Public: 05705244026254
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2026

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
• Device Model Number: FG000016-05
• Device Lot Number: 6010627
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2026
• Initial Report FDA Received Date: 04/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male