MAUDE Adverse Event Report: PALETTE LIFE SCIENCES DEFLUX INJECTABLE GEL; AGENT, BULKING, INJECTABLE FOR GASTR

Catalog Number	011503
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On april 09, 2025, palette life sciences received a notification from a [distributor] that was reported from a [hospital] in spain.It was reported that "during two operations in the children's operating room on two days in a row, the syringe has broken during the injection." additional information received on april 10, 2025, indicated that there was no injury to the patient or the physician, and the syringes broke at the joint between the wings and the body of the syringe.Two syringes are involved.Associated mdrs: 3014909464-2025-00016.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint evaluation testing was performed from the sample returned.Two almost empty syringe of the reported lot in return.Flange is broken off.Most likely the syringe was intact when received by the customer, breakage occurred during use.All other components look intact.There are no deviations or remarks identified in the review of batch records on the reported lot that can explain the complaint.No quality issues found connected to the raw material (glass syringe) which can explain the complaint.The most probable root cause could not be determined.No further actions will be taken regarding this complaint.Palette life sciences will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
On april 09, 2025, palette life sciences received a notification from a [distributor] that was reported from a [hospital] in spain.It was reported that "during two operations in the children's operating room on two days in a row, the syringe has broken during the injection." additional information received on april 10, 2025, indicated that there was no injury to the patient or the physician, and the syringes broke at the joint between the wings and the body of the syringe.Two syringes are involved.Associated mdrs: 3014909464-2025-00015 and 3014909464-2025-00016.

• Brand Name: DEFLUX INJECTABLE GEL
• Common Device Name: AGENT, BULKING, INJECTABLE FOR GASTR
• Manufacturer (Section D): PALETTE LIFE SCIENCES; santa barbara
• Manufacturer (Section G): PALETTE LIFE SCIENCES; 27 e cota st, suite 402; santa barbara
• Manufacturer Contact: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21955772
• Report Number: 3014909464-2025-00015
• Device Sequence Number: 9197661
• Product Code: LNM
• UDI-Device Identifier: 00850004725009
• UDI-Public: (01)00850004725009(11)231018(17)260930(10)21920-1(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P000029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: 011503
• Device Lot Number: 21920-1
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• 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