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

Catalog Number	011504
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "2 faulty deflux syringes.The nurses encountered the issue when attempting to use the item (deflux), finding the item broke on both occasions.Fortunately, in each instance, the item never made it to the patient, but we wanted to report the issue".Additional information received on january 24, 2026, indicated that there were no injuries or consequences, and pictures shared show only 1 syringe broken in the flange.
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer.The manufacturer reported: "this complaint has been handled and closed as code 3b (flange brake) based on the description, provided picture and sample.Visual inspection has been performed of the provided picture in terms of overall appearance.The picture displays one almost empty syringe with a broken flange.Lot number not visible, number of defective units is in accordance with the report.Code 3b applies.Returned sample inspection: one opened and almost empty syringe in return.The number of units and lot is in accordance with report.The syringe has a broken flange.Code 3b applies.The batch record has been reviewed and no deviations or anomalies were identified that can be linked to the complaint.No quality issues found connected to the raw material (syringe) which can explain the complaint.Identified root cause: not verified.No further actions will be performed within this complaint, however, the lot is monitored and if relevant, further investigation will be performed." teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "2 faulty deflux syringes.The nurses encountered the issue when attempting to use the item (deflux), finding the item broke on both occasions.Fortunately, in each instance, the item never made it to the patient, but we wanted to report the issue".Additional information received on january 24, 2026, indicated that there were no injuries or consequences, and pictures shared show only 1 syringe broken in the flange.

• Brand Name: US DEFLUX SYRINGE (1ML)
• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24407822
• Report Number: 3014909464-2026-00007
• Device Sequence Number: 13290243
• 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: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P000029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 011504
• Device Lot Number: 21918
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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