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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Production process review: we reviewed the production records of the affected batch and confirmed no abnormalities occurred during production.An investigation was conducted from the perspectives of man, machine, material, method and environment: 1) man: all production operators were properly trained and certified prior to taking up their posts.No operating errors were found, so this factor can be ruled out.2) machine: the products are assembled on automatic assembly machines.Daily equipment inspection is implemented.The machines are fitted with air-blowing devices to conduct patency check on each hypodermic needle and automatically reject defective products.Inspectors verify the detection function before each shift, and production will only start after normal function is confirmed.This factor can be ruled out.3) material: no changes were made to raw materials, so this factor can be ruled out.4) method: the production process remained unchanged.During and after siliconization, continuous air-blowing is applied to the needle tubing to prevent clogging caused by silicone oil.This factor can be ruled out.5) environment: the products are assembled and manufactured in a clean workshop.This factor can be ruled out.2.Retained sample testing: ten retained hypodermic needles (batch no.: ckde07-01, specification: 25g*1 1/2" (0.5mm*38mm)) were sampled for testing, with results as follows: visual inspection: the needle tube is straight and sharp.All components are intact with no foreign matter present.Five samples were tested for lumen patency in accordance with iso 7864:2016, and all test results met the requirements.Another five samples were subjected to simulated clinical aspiration and injection tests.All samples were unobstructed with no clogging observed.3.Root cause analysis: based on the above investigation and limited information provided by the customer, we put forward the following preliminary analysis on potential causes: clinicians may directly puncture medicine vials with the hypodermic needle for drug extraction.Rubber stopper debris may enter the needle lumen during puncture and cause clogging.The issue may be related to the use of high-concentration steroids, suspensions or oleaginous preparations.Such drugs feature high viscosity.If suspensions are not fully mixed, undissolved particles are likely to block the needle and stop the liquid flow.Since the defective clogged needle was not returned to us, we cannot identify the exact cause of clogging.The above analysis is only our preliminary judgment.
Event or Problem Description
Customer had multiple needles that were clogging with this lot.

• 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: 25497860
• Report Number: 3003560965-2026-00016
• Device Sequence Number: 16086745
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: CKDE07-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/14/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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