MAUDE Adverse Event Report: SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO MCKESSON BRANDS; NEEDLE, HYPO TW 25GX1"

Catalog Number	16-N251
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the needles inject approximately 0.5 to 1 ml and then stop, requiring multiple needle insertions to complete the injection.No information was received regarding any serious injury as a result of this product issue.

• Brand Name: MCKESSON BRANDS
• Common Device Name: NEEDLE, HYPO TW 25GX1"
• Manufacturer (Section D): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO; no.658, gaochao road, jiading; shanghai, shanghai 20180 3; CH 201803
• MDR Report Key: 23892266
• Report Number: 1451040-2025-00125
• Device Sequence Number: 5330099
• Product Code: FMI
• UDI-Device Identifier: 10612479206738
• UDI-Public: 10612479206738
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 12/25/2025
• Report Date (Section F): 12/25/2025

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: 16-N251
• Device Lot Number: CKDE01-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/05/2025
• Device Age: 11 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/25/2025
• 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: 12/25/2025