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

Catalog Number	011503
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On april 04, 2025, palette life sciences received a notification from a [distributor] in canada, in which it was reported that "the syringe breaks when the surgeon pushes the plunger.We had the same problem in september 2024, also on batch: 20852." additional information received on april 14, 2025, indicated that the procedure continued with another syringe, but the physician cut his finger due to the breakage of the syringe.Associated mdr reports: 3014909464-2025-00014.
Event or Problem Description
On april 04, 2025, palette life sciences received a notification from a [distributor] in canada, in which it was reported that "the syringe breaks when the surgeon pushes the plunger.We had the same problem in (b)(6) 2024, also on batch 20852." additional information received on april 14, 2025, indicated that the procedure continued with another syringe, but the physician cut his finger due to the breakage of the syringe.Associated mdr reports: 3014909464-2025-00013 and 3014909464-2025-00014.
Additional Manufacturer Narrative
(b)(4).Additional information received on may 02, 2025, indicated that "the doctor didn't need treatment to fix the cutting.She took off her gloves, wash her hands and put a small bandage on." complaint verification testing could not be performed as no sample was returned for analysis.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 were 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.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 (1ML)
• 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: 21930685
• Report Number: 3014909464-2025-00013
• Device Sequence Number: 15727365
• 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: CA
• PMA/510(K) Number: P000029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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: 011503
• Device Lot Number: 21920-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/15/2025
• 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