MAUDE Adverse Event Report: HANACO MEDICAL CO., LTD. MCKESSON BRANDS; NEEDLE, SPINAL QUINCKE 22GX3.5

Catalog Number	4631V2
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that on eight occasions, the spinal needles cracked in the view window and on the lure.The cracking happened during administration and small amounts of anesthetic were lost due to the issue.No information was received regarding any serious injury as a result of this reported issue.

• Brand Name: MCKESSON BRANDS
• Common Device Name: NEEDLE, SPINAL QUINCKE 22GX3.5
• Manufacturer (Section D): HANACO MEDICAL CO., LTD.; no. 129 dongting rd.; teda; tianjin, tianjin 30045 7; CH 300457
• MDR Report Key: 19605155
• Report Number: 1451040-2024-00031
• Device Sequence Number: 8486117
• Product Code: BSP
• UDI-Device Identifier: 10612479201566
• UDI-Public: 10612479201566
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 06/25/2024
• Report Date (Section F): 06/25/2024

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: 4631V2
• Device Lot Number: 2207064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/31/2024
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• 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: 06/25/2024