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

Catalog Number	011504
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during a cystoscopy with deflux injection procedure the syringe containing gel broke off the needle head on ad ministration.Surgeon requested another implant.A second & third implant was provided per surgeon request and administered by him.The defective implant was documented as "damaged" and pieces given to management for follow-up with manufacturer." multiple attempts for additional information have been requested from the complainant have been unsuccessful at the time of this report.Complaint received as a medwatch report.Mdr report#: mw5184023.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during a cystoscopy with deflux injection procedure the syringe containing gel broke off the needle head on ad ministration.Surgeon requested another implant.A second & third implant was provided per surgeon request and administered by him.The defective implant was documented as "damaged" and pieces given to management for follow-up with manufacturer." multiple attempts for additional information have been requested from the complainant have been unsuccessful at the time of this report.Complaint received as a medwatch report.Mdr report#: mw5184023.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.If the sample becomes available at a later date a follow-up report will be submitted with investigation results.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: DEFLUX SYRINGE
• Common Device Name: AGENT, BULKING, INJECTABLE
• 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: 24840829
• Report Number: 3014909464-2026-00028
• Device Sequence Number: 9799728
• Product Code: LNM
• UDI-Device Identifier: 00850004725009
• UDI-Public: (01)00850004725009(11)240216(17)270131(10)22223(21)
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 011504
• Device Lot Number: 22223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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