MAUDE Adverse Event Report: MCKESSON; EPIDURAL NEEDLE

Model Number	3076V2
Health Effect - Clinical Code	Hematoma (1884)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that multiple spinal needles.

• Brand Name: MCKESSON
• Common Device Name: EPIDURAL NEEDLE
• MDR Report Key: 12502006
• Report Number: 1058382-2021-00001
• Device Sequence Number: 5122182
• Product Code: BSP
• UDI-Device Identifier: 10612479201689
• UDI-Public: 10612479201689
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/14/2021
• Report Date (Section F): 09/14/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2025
• Device Model Number: 3076V2
• Device Catalogue Number: TU18G350
• Device Lot Number: 2003562
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/01/2021
• Device Age: 9 MO
• Date Report to Manufacturer: 09/14/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other