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	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when the item was to be utilised (injected) it failed and broke off during the preparation.This occurred on both occasions." no injuries or consequences reported.2 syringes reported.Associated mdrs: 3014909464-2026-00054.
Additional Manufacturer Narrative
(b)(4).

• 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: 25417147
• Report Number: 3014909464-2026-00053
• Device Sequence Number: 21221538
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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 Catalogue Number: 011518
• Device Lot Number: 22224-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 07/07/2026
• 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.
• Patient Sex: Unknown