MAUDE Adverse Event Report: PALETTE LIFE SCIENCES US DEFLUX SYRINGE (1ML); AGENT, BULKING, INJECTABLE

Catalog Number	011504
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "last night i received a call from a doctor from the (b)(6).The doctor was using deflux for a patient with vur (vesicoureteric reflux).She used an alternative needle (not a deflux needle).The needle became clogged, and she tried to force it through.The syringe ended up breaking".Additional information received on january 15, 2026, indicated that "patient was under anesthesia, if a deluxe needle were available, the procedure could have been completed with another syringe.Injetak adjustable tip needle 35cm was used.Indication of deflux was vur in a child.While administering, the glass syringe shattered at the plunger, and the surgeon was injured due to the event.The glass was removed, cuts washed out, and bandaged.".
Additional Manufacturer Narrative
(b)(4).The complaint was evaluated and closed as broken flange based on the complaint description, photographic evidence, and examination of the returned sample.A visual assessment of the submitted image confirmed the presence of an empty syringe with a broken flange.The reported lot number and quantity of affected units are consistent with the information provided.One unit was returned for evaluation.Examination of the sample confirmed a broken flange, consistent with the reported condition and classification of the complaint record.A review of the batch record did not identify any deviations or anomalies that could be associated with the reported issue.Addition ally, no quality concerns related to the raw material (syringe) were identified that would explain the event.The probable cause could not be determined from the available information.Palette will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "last night i received a call from a doctor from (b)(6).The doctor was using deflux for a patient with vur (vesicoureteric reflux).She used an alternative needle (not a deflux needle).The needle became clogged, and she tried to force it through.The syringe ended up breaking".Additional information received on january 15, 2026, indicated that "patient was under anesthesia, if a deluxe needle were available, the procedure could have been completed with another syringe.Injetak adjustable tip needle 35cm was used.Indication of deflux was vur in a child.While administering, the glass syringe shattered at the plunger, and the surgeon was injured due to the event.The glass was removed, cuts washed out, and bandaged.".

• Brand Name: US DEFLUX SYRINGE (1ML)
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24270716
• Report Number: 3014909464-2026-00003
• Device Sequence Number: 16116885
• Product Code: LNM
• UDI-Device Identifier: 00850004725009
• UDI-Public: (01)00850004725009(11)231016(17)260930(10)21918(21)
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 011504
• Device Lot Number: 21918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• 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
• Patient Weight: 17 KG