MAUDE Adverse Event Report: DR. JAPAN CO., LTD. MCKESSON; EPIDURAL NEEDLE

Model Number 3076V2

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Type  Injury  

Event Description

It was reported that multiple spinal needles.

• Brand Name: MCKESSON
• Type of Device: EPIDURAL NEEDLE
• Manufacturer (Section D): DR. JAPAN CO., LTD.; 4-15-1 nagano; gyoda city, saitama 361-0 ; JA 361-0
• MDR Report Key: 12502006
• MDR Text Key: 272511791
• Report Number: 1058382-2021-00001
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 10612479201689
• UDI-Public: 10612479201689
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other