MAUDE Adverse Event Report: MEDLINE; NEEDLE,18GX1.0",REG,BEVEL,ST

Catalog Number	SYR100185
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: NEEDLE,18GX1.0",REG,BEVEL,ST
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50746950
• Report Number: 1417592-2026-38563
• Device Sequence Number: 16011425
• Product Code: FMI
• UDI-Device Identifier: 40080196304944
• UDI-Public: 40080196304944
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/12/2026

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
• Device Catalogue Number: SYR100185
• Device Lot Number: 220610
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 09/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown