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	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer stated that the needles seem to be blocked.
Additional Manufacturer Narrative
1.Production process review.The production records of this batch were reviewed, and no abnormalities were identified during production.Investigation and analysis were performed from the following perspectives: man: production operators were adequately trained and certified prior to taking up their posts.No product mix up occurred; therefore, this factor can be ruled out.Machine: the product was assembled on an automatic assembly machine.Daily equipment checks were performed.The machine was equipped with an air blowing device to detect lumen blockage for each hypodermic needle and automatically reject non conforming units.Prior to each shift, inspectors verified the detection function of the equipment, and production commenced only upon confirmation of proper function.This factor can therefore be ruled out.Material: no changes were made to raw materials, so inherent material related causes can be excluded.Nevertheless, this specification features a relatively fine inner lumen of the needle cannula.Information regarding clinically administered drugs is unavailable.High concentration drugs or steroid medications may potentially result in difficult injection.Method: no modifications were implemented to the production process.Automatic assembly equipment was used for product assembly.Air blowing control was applied to needle tube during and after siliconization to prevent silicone oil induced blockage.Accordingly, this factor can be ruled out.In addition, clinical practice may involve direct puncture of drug vials with hypodermic needles for drug aspiration.Rubber stopper particulates may be generated during needle tip puncture, which could cause cannula blockage.Environment: products were assembled in a clean room workshop; this factor can be ruled out.2.Retained sample testing.10 retained samples of hypodermic needle, batch no.Ckdc1201, size 27g*1/2" (0.4mm*13mm), were subjected to testing as follows: 1) visual inspection: needle tubes were straight with sharp tips; all components were intact and free of foreign matter.2) five samples were tested for lumen patency in accordance with iso 7864:2016.Test results met specification requirements; 3) five samples were subjected to simulated clinical aspiration and injection testing.All samples showed unobstructed flow with no blockage; 3.Cause analysis.Since the defective blocked needle involved in this complaint was not returned to our company, the preliminary potential causes concluded based on the above investigation are listed as follows: 1) the blockage may be caused by rubber stopper particulates entering the needle tube when the needle tip directly punctures the drug vial for liquid extraction in clinical operation.2) difficult injection may result from the use of high-concentration drugs or steroid drugs during clinical administration.

• 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: 50466115
• Report Number: 3003560965-2026-00029
• Device Sequence Number: 15995515
• 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): 08/21/2026

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: CKDC12-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown