MAUDE Adverse Event Report: HANACO MEDICAL CO., LTD. MCKESSON BRANDS; NEEDLE, SPINAL QUINCKE 25GX3.5

Catalog Number 4632V2

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2023

Event Type  malfunction  

Event Description

It was reported by the customer that the medication leaks out of the hub when they use these needles.No information was received regarding any serious injury as a result of this reported issue.

• Brand Name: MCKESSON BRANDS
• Type of Device: NEEDLE, SPINAL QUINCKE 25GX3.5
• Manufacturer (Section D): HANACO MEDICAL CO., LTD.; no. 129 dongting rd.; teda; tianjin, tianjin 30045 7; CH 300457
• MDR Report Key: 18171526
• MDR Text Key: 328549281
• Report Number: 1451040-2023-00054
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2023

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 Operator: Health Professional
• Device Catalogue Number: 4632V2
• Device Lot Number: 2203566
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2023
• Distributor Facility Aware Date: 10/30/2023
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1