MAUDE Adverse Event Report: PALETTE LIFE SCIENCES DEFLUX SYRINGE; AGENT, BULKING, INJECTABLE FOR GASTR

Catalog Number	011518
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "[physician] was performing a deflux case.[physician] first injected one syringe of deflux.Then, upon injecting the second syringe of deflux, the glass collar holding the flange in place snapped off.There was no injury to the surgeon." additional information received on december 21, 2025, indicated that "the procedure proceeded without awakening the patient, and the procedure was completed.Another syringe was not required as the issue occurred when the syringe was almost empty.A deflux metal needle was used.".
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer.The manufacturer reported: "this complaint has been handled and closed as code 3b (broken flange) based on provided complaint description, pictures and inspection of returned sample.Inspection of sample: one almost empty syringe in return.Number of units and lot are in accordance with the report.The syringe has a broken flange.Picture: visual inspection has been performed of provided picture in terms of overall appearance.Picture displays one almost empty syringe with a broken flange.There are no deviations or remarks identified in the review of batch records on the reported lot that can explain the complaint no quality issues found connected to the raw material (glass syringe) which can explain the complaint.The most probable root cause: not determined.No further actions will be performed within this complaint, however, the lot is monitored and if relevant, further investigation will be performed." teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "[physician] was performing a deflux case.[physician] first injected one syringe of deflux.Then, upon injecting the second syringe of deflux, the glass collar holding the flange in place snapped off.There was no injury to the surgeon." additional information received on december 21, 2025, indicated that "the procedure proceeded without awakening the patient, and the procedure was completed.Another syringe was not required as the issue occurred when the syringe was almost empty.A deflux metal needle was used.".

• Brand Name: DEFLUX SYRINGE
• Common Device Name: AGENT, BULKING, INJECTABLE FOR GASTR
• Manufacturer (Section D): PALETTE LIFE SCIENCES; santa barbara CA
• Manufacturer (Section G): PALETTE LIFE SCIENCES; 27 e cota st, suite 402; santa barbara CA 93101
• Manufacturer Contact: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24082645
• Report Number: 3014909464-2026-00002
• Device Sequence Number: 9696548
• Product Code: LNM
• UDI-Device Identifier: 00850004725009
• UDI-Public: (01)00850004725009(11)240216(17)270131(10)22224-1(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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 Catalogue Number: 011518
• Device Lot Number: 22224-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown