MAUDE Adverse Event Report: ETHICON, LLC ETHICON; SUTURE, ABSORBABLE, NATURAL

Model Number	1915G
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) noticed the tip of one of the 5.0 fast absorbing needle tip was missing.Staff compared it to another suture and was indeed missing.Dr.(b)(6) immediately went to look for tip in patient's tongue.It was located and placed into a specimen cup.Xray ordered to confirm there was no remaining suture.Xray read by dr.(b)(6) did not see any residual suture left in the tongue.

• Brand Name: ETHICON
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON, LLC; 475 c street, suite 401; los frailes industrial park; guaynabo PR 00969
• MDR Report Key: 22352627
• Report Number: 22352627
• Device Sequence Number: 12782805
• Product Code: GAL
• UDI-Device Identifier: 10705031002913
• UDI-Public: (01)10705031002913
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025
• Report Date (Section F): 06/20/2025

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
• Device Model Number: 1915G
• Device Catalogue Number: 1915G
• Device Lot Number: 103DT3
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/20/2025