MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO.,LTD MCKESSON BRANDS; NEEDLE, HYPO RW 30GX1/2"

Catalog Number	16-N3005
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that while the facility was administering a dental block, the needle detached from its base and became lodged in the patient's gum.

• Brand Name: MCKESSON BRANDS
• Common Device Name: NEEDLE, HYPO RW 30GX1/2"
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO.,LTD; no.23 huanxi rd; zhutang town; jiangyin,, jiangsu ; CH
• MDR Report Key: 23889682
• Report Number: 1451040-2025-00124
• Device Sequence Number: 9650669
• Product Code: FMI
• UDI-Device Identifier: 10612479207384
• UDI-Public: 10612479207384
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/24/2025
• Report Date (Section F): 12/24/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 16-N3005
• Device Lot Number: CJCD10-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/05/2025
• Device Age: 14 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/24/2025
• 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: 12/24/2025