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

Catalog Number	16-N3005
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that doctors have difficulty with the insertion for intravitreal (eye) injections.The doctor took a closer look at the needle under a microscope in which he discovered the needles were ridged and barbed.No information was received regarding any serious injury as a result of this product issue.

• 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: 24269300
• Report Number: 1451040-2026-00009
• Device Sequence Number: 10726690
• Product Code: FMI
• UDI-Device Identifier: 10612479207384
• UDI-Public: 10612479207384
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/05/2026
• Report Date (Section F): 02/05/2026

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 Catalogue Number: 16-N3005
• Device Lot Number: CJCE03-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/27/2026
• Device Age: 11 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• 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: 02/05/2026