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

Model Number	26G*1/2''(0.46MM*13MM)
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) batch sample test: on november 11, 2024, batch number: ckdd06-03 specification model: 26g / 1/2''(0.46mm /13mm), 20 needles retention sample products were selected for the following tests: 1.Patency test of needle lumen: according to the requirements of iso7864-2016(e) standard, 10 samples were taken for testing.The 0.18mm stylet was used to pass through the needle lumen, and the stylet could be dropped freely.2.Simulated clinical use for suction injection test: 10 needles were taken to simulate clinical practice for suction injection liquid, and the simulation test results: all of them were unobstructed without blockage.(2) production process review: upon inspection of the production records of this batch of products, there were no abnormalities in the production process, and there were no changes in the raw materials and production processes of the products.
Event or Problem Description
The customer reported that no fluid is released from the needle during injections.

• 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: kim chi ; no. 758, 5th binhai road; longwan district; wenzhou, zhejiang 32502-5 ; CH 325025
• MDR Report Key: 20756802
• Report Number: 3003560965-2024-00083
• Device Sequence Number: 18283119
• Product Code: FMI
• UDI-Device Identifier: 10612479206820
• UDI-Public: 10612479206820
• 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): 11/22/2024

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: 26G*1/2''(0.46MM*13MM)
• Device Catalogue Number: 16-N2605
• Device Lot Number: CKDD06-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/22/2024
• 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