MAUDE Adverse Event Report: MYCO MEDICAL SUPPLIES, INC MCKESSON; NEEDLE, SPINAL QUINCKE 22GX5"

Catalog Number	4633V2
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the needle appears to have not been fully bored through, which prevented the medication from being administered.No information was received regarding any serious injury as a result of this product issue.
Additional Manufacturer Narrative
An additional lot number was added after confirming the same issue was present.This follow-up serves as supplementary information to the initial report.

• Brand Name: MCKESSON
• Common Device Name: NEEDLE, SPINAL QUINCKE 22GX5"
• Manufacturer (Section D): MYCO MEDICAL SUPPLIES, INC; 158 toverview court; cary NC 27513
• MDR Report Key: 22713287
• Report Number: 1451040-2025-00060
• Device Sequence Number: 15754837
• Product Code: FMI
• UDI-Device Identifier: 10612479201597
• UDI-Public: 10612479201597
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025
• Report Date (Section F): 08/18/2025

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: 4633V2
• Device Lot Number: 2210655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/18/2025
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/18/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/18/2025
• 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: 08/18/2025