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

Model Number	30G*1/2''(0.3MM*13MM)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The needle point of the needle is easy to break.
Additional Manufacturer Narrative
1.Production process review: the production records of the batch were reviewed, and no abnormalities were found during the manufacturing process.The investigation was conducted from the following aspects: personnel: all production operators were trained and certified before working on the production line.Since the product is assembled using an automatic assembly machine and no processing errors were found, this factor can be ruled out.Equipment: production equipment undergoes daily inspections and regular maintenance.Additionally, first-piece inspections are performed at the start of each shift, with no abnormalities detected, eliminating this factor.Materials: there were no changes in raw materials.Needle tubes undergo rigidity and toughness testing during incoming inspection and are only used if compliant.Finished products also undergo rigidity and toughness testing before release, ruling out this factor.Method: no changes were made to the production process, so the influence of process variations can be excluded.However, the needle tubes of this specification are relatively thin and prone to bending under force.If the bending angle during clinical operation is too large, breakage may occur.Environment: the product is assembled in a cleanroom environment.Since the needle breakage occurred during use, it is unrelated to the production environment.2.Batch sample testing: a sample of 10 sample from batch ckde01-01, specification 30g*1/2'' (0.3mm*13mm), was tested as follows: visual inspection confirmed that the adhesive bonding between all needle tubes and hubs was complete, with no abnormalities.10 sample were subjected to rigidity and toughness testing per iso 7864:2016, with all samples passing and no breakage observed.3.Root cause analysis: based on the investigation, the likely cause is that the needle tube is relatively thin.During clinical use, improper handling or excessive patient movement may cause the needle tube to bend beyond its tolerable range (normal limit: 25 (ã), leading to breakage.

• 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: 22871930
• Report Number: 3003560965-2025-00016
• Device Sequence Number: 5687734
• Product Code: FMI
• UDI-Device Identifier: 10612479207384
• UDI-Public: 10612479207384
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 30G*1/2''(0.3MM*13MM)
• Device Catalogue Number: CKDE01-01
• Device Lot Number: 16-N3005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• 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