MAUDE Adverse Event Report: MYCO MEDICAL SUPPLIES, INC MCKESSON BRAND; NEEDLE, SPINAL QUINCKE 25GX3.5

Catalog Number	4632V2
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that after inserting the spinal needle, they were unable to inject through it.It appears that the distal end may not be fully open.No information was received regarding any serious injury as a result of this product issue.

• Brand Name: MCKESSON BRAND
• Common Device Name: NEEDLE, SPINAL QUINCKE 25GX3.5
• Manufacturer (Section D): MYCO MEDICAL SUPPLIES, INC; 158 toverview court; cary NC 27513
• MDR Report Key: 22684928
• Report Number: 1451040-2025-00058
• Device Sequence Number: 9473176
• Product Code: FMI
• UDI-Device Identifier: 10612479201658
• UDI-Public: 10612479201658
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2025
• Report Date (Section F): 08/01/2025

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 Catalogue Number: 4632V2
• Device Lot Number: 2211345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/11/2025
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/01/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/01/2025