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

Model Number	30G×1/2" (0.3MM×13MM)
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer claims that the needles are poking through caps.
Additional Manufacturer Narrative
Upon receiving customer feedback regarding " the needles are poking through caps," our company promptly organized quality control, production, and related personnel to investigate the situation.Specific details are as follows: (1) production process review: upon tracing back the production batch records of lot: ckdc10-01 batch products, and there are no abnormalities in the production process.The raw materials and production processes have not changed.(2) retained sample testing: 50 samples from the batch were extracted for visual inspection, and the hypodermic needles tubes were straight, smooth, and without defects.No bending or piercing of the protective sheath was found.(3) root cause analysis: based on customer feedback and the analysis of the production process and manufacturing techniques of the hypodermic needles products, it is speculated that the user was stabbed by the needle when putting back the protective sleeve after clinical use of hypodermic needles.

• Brand Name: MCKESSON
• Common Device Name: HYPODERMIC NEEDLES
• Manufacturer (Section D): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758, 5th binhai road; longwan district; wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer (Section G): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758, 5th binhai road; longwan district; wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer Contact: kim chi ; no. 758, 5th binhai road; longwan district; wenzhou, zhejiang 32502-5 ; CH 325025
• MDR Report Key: 19709398
• Report Number: 3003560965-2024-00068
• Device Sequence Number: 3239143
• 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
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

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: 30G×1/2" (0.3MM×13MM)
• Device Catalogue Number: 16-N3005
• Device Lot Number: CKDC10-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 07/10/2024
• 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