MAUDE Adverse Event Report: ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD MCKESSON; NEEDLES

Model Number	25G×5/8'' (0.5MM*16MM)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the needle would break while injecting patient.
Additional Manufacturer Narrative
1.Production process review: check the production records of this batch of products, ensure that there are no abnormalities in the production process, and investigate from the following aspects: person: all production employees have undergone training and passed the assessment before taking up their posts, and the product is assembled using an automatic assembly machine without any processing errors.This factor can be ruled out.Machine: production equipment undergoes daily inspections and regular maintenance, and the first inspection of processed products is conducted every shift.No abnormalities were found, and this factor can be ruled out.Material: the raw materials of the product have not changed.During the needle tube inspection, rigidity and toughness testing will be carried out, and only after passing the testing can it be put into use.The finished product inspection will also undergo rigidity and toughness testing, and only after passing the testing can it be released.The factors can be excluded.Method: the process of the product has not changed, and the influence of process changes can be ruled out.The needle tube of this specification is relatively thin and prone to bending under force.If the bending angle of the needle tube is too large during clinical operation, it may break.Environment: this product is assembled and produced in a clean workshop, and the needle tube breakage is due to use and is not related to the production environment.2.Sample retention inspection: sampling batch number: ckdj09-02 specification: 25g*5/8 '' (0.5mm *16mm) hypodermic needle retention sample of 10 for testing: 1) upon inspection, all needle tubes and needle hubs were filled with adhesive and no abnormalities were found.2) ten samples were selected for rigidity and toughness testing according to the requirements of iso 7864:2016 standard.After testing, all samples were qualified and no fracture occurred.

• Brand Name: MCKESSON
• 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: suhua li ; no.758,5th binhai road; wenzhou, zhejiang 32502-5 ; CH 325025
• MDR Report Key: 23388304
• Report Number: 3003560965-2025-00029
• Device Sequence Number: 10034282
• 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): 10/27/2025

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: 08/02/2025
• Device Model Number: 25G×5/8'' (0.5MM*16MM)
• Device Lot Number: CKDJ09-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 10/27/2025
• 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