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	Laceration(s) (1946)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "surgeon was using the deflux gel syringe and when she tried to start pushing the contents out, she was met with more resistance than normal, and the syringe completely shattered, resulting in a laceration on her finger.The surgeon uses this product frequently and has never had issues with it, so she believes it might be a faulty lot." additional information received on april 28, 2026, indicated that "the patient was under anesthesia, and the procedure could proceed without awaking the patient with another syringe.The deflux metal needle was used.The indication was vur in a child.No injuries reported." the photograph provided by the customer shows a superficial laceration on the finger.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "surgeon was using the deflux gel syringe and when she tried to start pushing the contents out, she was met with more resistance than normal, and the syringe completely shattered, resulting in a laceration on her finger.The surgeon uses this product frequently and has never had issues with it, so she believes it might be a faulty lot." additional information received on april 28, 2026, indicated that "the patient was under anesthesia, and the procedure could proceed without awaking the patient with another syringe.The deflux metal needle was used.The indication was vur in a child.No injuries reported." the photograph provided by the customer shows a superficial laceration on the finger.
Additional Manufacturer Narrative
(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.Picture: visual inspection has been performed of provided picture in terms of overall appearance.Two images were reviewed.The first image shows a finger with a cut, indicating that the healthcare professional (hcp) may have been injured by the glass syringe.The second image shows a box with the reported lot number.However, no image of the damaged (broken flange) syringe is provided.The images do not allow verification of the complaint, as the defective syringe is not shown.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.Palette life sciences 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: 25247396
• Report Number: 3014909464-2026-00049
• Device Sequence Number: 10500996
• Product Code: LNM
• UDI-Device Identifier: 00850004725009
• UDI-Public: (01)00850004725009(11)241215(17)271130(10)23150(21)
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P000029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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 Catalogue Number: 011504
• Device Lot Number: 23150
• 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: 04/28/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2024
• 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