MAUDE Adverse Event Report: ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. MCKESSON GLOBAL SOURCING LTD; NEEDLE

Model Number	25G*5/8''(0.5MM*16MM)
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Production process review: the production records of the batch were checked, and no abnormalities were found in the production process.The raw materials and production process for the product remained unchanged.This batch is consistent with the complaint (2025-mckesson-0202/gl-25-0063).2.Batch sample testing: on (b)(6) 2025, 10 samples of the hypodermic needles from batch number ckdj08-04, specification 25g*5/8" (0.5mm*16mm), were tested as follows: - 1) needle lumen patency test: according to the iso7864-2016(e) standard, 5 samples were tested by inserting a 0.23mm stylet into the needle lumen.The stylet passed through freely and fell out in all cases.Test results: all passed.- 2) simulated clinical use for liquid aspiration and injection test: 5 sample needles were tested individually by simulating clinical liquid aspiration and injection.Simulated test results: all were unobstructed with no blockages.3.Cause analysis: the above sample testing and production process review did not reveal any such abnormalities.Based on customer feedback, the preliminary analysis of the causes for the needle blockage is as follows: 1) silicone oil blockage in the needle: the hypodermic needles undergo full inspection for blockages online after siliconization during production.Any blockages are automatically removed.The siliconization process includes air blowing control.Additionally, to address needle patency issues, a dedicated inspector is assigned at the start of each shift to test the sensitivity of the assembly machine with specially designed defective products before production begins.Each batch undergoes initial inspection before production, periodic sampling during production (once every 4 hours), and final product inspection after production.No such blockage issues were found throughout the production and final inspection processes, making the likelihood of this factor very low.2) blockage due to coring and fragmentation: it is common in clinical settings to use hypodermic needles to pierce medication vial stoppers for drug addition and extraction.Particulate matter from the stoppers can lead to needle blockages.
Event or Problem Description
It has been reported that this particular lot of needles is not effectively administering medications.The customer indicated that the needles from this lot were unable to push methylprednisolone and other drugs through as expected.

• 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: 21604947
• Report Number: 3003560965-2025-00011
• Device Sequence Number: 18445954
• Product Code: FMI
• UDI-Device Identifier: 10612479206790
• UDI-Public: 10612479206790
• Combination Product (Y/N): N
• PMA/510(K) Number: K112057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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 Expiration Date: 07/04/2025
• Device Model Number: 25G*5/8''(0.5MM*16MM)
• Device Lot Number: CKDJ08-04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/14/2025
• 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