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

Catalog Number	011518
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "[physician] was performing deflux implant in adult vur patient.He had successfully implanted 2ml (2 x 1ml syringes) through the deflux needle.[physician] attached a 3rd syringe, and as he was implanting, the base of the glass syringe snapped off.The affected syringe was placed to the side, and a fourth syringe was attached.This syringe also snapped at the base, and the glass from the syringe sliced open the lateral aspect of the surgeon's middle finger.The injury was approximately 1cm long.The surgeon was unable to complete the procedure due to the last two deflux syringes both snapping at the base.The patient did not experience an adverse event; it was an injury to the operating surgeon." syringes involved 2.Associated mdrs: 3014909464-2025-00026.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Additional information received on july 20, 2025, indicated that "the surgeon said that the cut was superficial and did not require suturing/surgery.2ml of deflux was used in this patient, and it seemed sufficient during the procedure.The procedure was completed without awakening the patient." complaint evaluation testing was performed from the two samples returned.Two used syringes in return.Number of units and lot is in accordance with the report.Both syringes have a broken/missing flange.No other damages are visible.Most likely the flange broke off during use.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 taken regarding this complaint.Palette life sciences will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "[physician] was performing deflux implant in adult vur patient.He had successfully implanted 2ml (2 x 1ml syringes) through the deflux needle.[physician] attached a 3rd syringe, and as he was implanting, the base of the glass syringe snapped off.The affected syringe was placed to the side, and a fourth syringe was attached.This syringe also snapped at the base, and the glass from the syringe sliced open the lateral aspect of the surgeon's middle finger.The injury was approximately 1cm long.The surgeon was unable to complete the procedure due to the last two deflux syringes both snapping at the base.The patient did not experience an adverse event; it was an injury to the operating surgeon." syringes involved 2.Associated mdrs: 3014909464-2025-00026 and 3014909464-2025-00025.

• Brand Name: DEFLUX INJECTABLE GEL
• 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22171364
• Report Number: 3014909464-2025-00025
• Device Sequence Number: 7798987
• 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
• PMA/510(K) Number: P000029
• 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): 05/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 011518
• Device Lot Number: 22224-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 08/21/2025
• 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 Age: 45 YR
• Patient Sex: Unknown