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	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 "the deflux gel failed to come out of the syringe after the plunger was pushed; therefore, the gel could not go through the deflux metal needle.The patient was able to receive their deflux dose using a third syringe that had no issues.There were no missed doses or adverse events.For one of the syringes, the wings broke off, and none of the medication came out.The patient was under anesthesia, and the case proceeded without awakening the patient with another syringe.Indication for use: vesicoureter-reflux with reflux nephropathy with hydroureter in a child.No patient injury or consequence reported.".
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: this complaint has been handled and closed as code 3b (broken flange) applies according to the complaint description and inspection of the returned sample.Returned sample inspection: one syringe in return.Number of units and lot is in accordance with 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 full 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 previous similar reported complaints on the lot.No quality issues found connected to the raw material 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.Palette life sciences will continue to monitor and trend for reports of this nature.Will continue to monitor and trend for reports of this nature." other remarks: n/a corrected data: n/a.

• 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25493937
• Report Number: 3014909464-2026-00069
• Device Sequence Number: 9716328
• Product Code: LNM
• UDI-Device Identifier: 00850004725009
• UDI-Public: (01)00850004725009(11)240815(17)270815(10)22747(21)
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2026

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: 22747
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2024
• 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