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

Model Number	27G*1/2''(0.4mm*13mm)
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported having a lot of issues with the needles not working with the syringes.Per customer response: the needles when attached to these syringes(1 cc syringes) do not fit securely and we have had medication spilling out because of the pressure between the syringe and needle when administering, it pops out.
Additional Manufacturer Narrative
Production process review: the batch production records and finished product release inspection reports for this batch of product were traced.No abnormalities were identified during production or finished product inspection.Retained sample testing: ten retained samples of injection needle, batch no.: ckdd08-01, size: 27g*1/2" (0.4mm*13mm), were sampled for testing: visual inspection: all needle hubs were intact with no damage or cracking.Luer adapter tests (axial load resistance to separation test / unscrewing torque resistance to separation test) were performed in accordance with iso 80369-7.All test results complied with requirements; simulated clinical injection was performed after connection to luer lock syringes and luer slip syringes respectively.Normal function was achieved in all tests, and no needle detachment occurred.Root cause analysis: based on the above investigation and customer feedback, the potential root causes are preliminarily analyzed as follows: the hypodermic needle was not fully tightened when assembled to the syringe during clinical use, resulting in needle detachment from the syringe and drug leakage in clinical application.Mismatch between the luer adapter dimensions of the syringe and the hypodermic needle, leading to insufficient connection tightness.

• Brand Name: McKesson Global Sourcing Ltd
• Common Device Name: Needle
• 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: suhua li ; no.758,5th binhai road; wenzhou, zhejiang 32502-5 ; CH 325025
• MDR Report Key: 50687293
• Report Number: 3003560965-2026-00033
• Device Sequence Number: 10348889
• Product Code: FMI
• UDI-Device Identifier: 10612479206851
• UDI-Public: 10612479206851
• 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): 09/07/2026

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: 27G*1/2''(0.4mm*13mm)
• Device Lot Number: CKDD08-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/09/2026
• 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