MAUDE Adverse Event Report: Zhejiang Kindly Medical Devices Co., Ltd. McKesson Global Sourcing Ltd; Needles

Model Number	25G*1 1/2''(0.5mm*38mm)
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported having a lot of issues with the needles not working with the syringes.
Additional Manufacturer Narrative
1.Production process review: the production records of this batch were reviewed.No changes were identified in raw materials or manufacturing process of the product.Operators performed first inspection and in-process inspection as required, and no abnormalities were found during production.2.Retained sample testing: ten retained samples of lot ckde11-01, specification 25g * 1 1/2" (0.5 mm*38 mm) hypodermic needles were sampled for testing: 1)visual inspection: products were intact with no damage.2) pressure decay leak test and positive-pressure liquid leak test: all test results were acceptable 3) taper test of the hypodermic needle conical fitting: all test results complied with standard requirements 4) after connection with luer slip and luer lock syringes respectively, simulated clinical aspiration and injection of liquid were performed.Normal aspiration and injection were achieved with no leakage observed; 3.Root cause analysis: based on the above investigation, the customer-reported issue could not be reproduced during retained sample testing.Due to limited information provided by the customer, the preliminary potential causes identified by our company are as follows: 1)the hypodermic needle was not fully tightened to the syringe prior to clinical use, resulting in leakage during injection.2)the luer fitting dimension of the customer's syringe was non-compliant with relevant standards, leading to poor connection and subsequent leakage.

• Brand Name: McKesson Global Sourcing Ltd
• Common Device Name: Needles
• Manufacturer (Section D): Zhejiang Kindly Medical Devices Co., Ltd.; no. 758, 5th binhai road; wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer (Section G): Zhejiang Kindly Medical Devices Co., Ltd.; no. 758, 5th binhai road; wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer Contact: linjuan yao ; no 658., gao chao rd.; jiading shanghai, shanghai 20180-3 ; CH 201803
• MDR Report Key: 50864352
• Report Number: 3003560965-2026-00038
• Device Sequence Number: 10673844
• Product Code: FMI
• UDI-Device Identifier: 10612479206769
• UDI-Public: 10612479206769
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: 25G*1 1/2''(0.5mm*38mm)
• Device Lot Number: CKDE11-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown