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)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Review of production process: examine the production records of the batch, which showed no abnormalities during the process.The investigation was conducted from the following aspects: personnel: production operators were trained and certified before starting work, and the product was manufactured correctly, ruling out this factor.Machine: the product was assembled using an automatic assembly machine.The equipment underwent daily checks and was equipped with an air-blowing device to detect needle blockages, automatically rejecting defective products.Before each shift, inspectors verified the machine's detection function, and production only proceeded if it was functioning normally, thus ruling out this factor.Materials: there were no changes in the raw materials, ruling out this factor.Method: the production process remained unchanged.The product was assembled using an automatic assembly machine, and during and after the siliconization process, the needle tubes were continuously blown with air to prevent silicone oil blockages, ruling out this factor.Environment: the product was assembled in a cleanroom environment, ruling out this factor.2.Batch sample testing: a sample of 10 retained units from batch number ckdd12-01, specification 25g*5/8'' (0.5mm*16mm) hypodermic needles, was tested as follows: 5 samples were tested for lumen patency in accordance with iso 7864:2016, and the results met requirements.5 samples underwent simulated clinical use for liquid aspiration and injection testing, with all samples demonstrating no blockages and full patency.3.Root cause analysis: based on the above investigation, the likely cause is clinical practice of using the hypodermic needles directly to puncture medication vials for drug reconstitution.During needle penetration of the rubber stopper, rubber particles may dislodge and block the needle lumen.Hypodermic needles are primarily designed for subcutaneous human injection and are not recommended for direct drug withdrawal or reconstitution.If drug aspiration or reconstitution is required in clinical settings, we recommend using our dedicated reconstitution needles, which are specifically designed to minimize rubber particle generation.
Event or Problem Description
The complaint reported that the needles failed to inject into the patient due to clogging.

• 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: 22871889
• Report Number: 3003560965-2025-00015
• Device Sequence Number: 5803322
• Product Code: FMI
• UDI-Device Identifier: 20612479206803
• UDI-Public: 20612479206803
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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 Model Number: 25G*5/8''(0.5MM*16MM)
• Device Catalogue Number: 16-N2558
• Device Lot Number: CKDD12-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/22/2025
• 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