MAUDE Adverse Event Report: HANACO MEDICAL CO., LTD. MCKESSON BRANDS; NEEDLE, SPINAL QUINCKE 20GX3.5

Catalog Number 4629V2

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/09/2023

Event Type  Injury  

Event Description

It was reported by the customer that the hub of the needle broke off during a procedure and had to be retrieved.It was communicated that there were no concerns with the delivery of the meds.

• Brand Name: MCKESSON BRANDS
• Type of Device: NEEDLE, SPINAL QUINCKE 20GX3.5
• Manufacturer (Section D): HANACO MEDICAL CO., LTD.; no. 129 dongting rd.; teda; tianjin, tianjin 30045 7; CH 300457
• MDR Report Key: 18055132
• MDR Text Key: 327156468
• Report Number: 1451040-2023-00052
• 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: 11/02/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4629V2
• Device Lot Number: 2202549
• 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: 11/02/2023
• Distributor Facility Aware Date: 10/09/2023
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other