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

Model Number	30G*1/2"
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
Upon receiving customer feedback regarding the "50 needles from their order have been clogged," our company promptly organized quality control, production, and related personnel to investigate the situation.Specific details are as follows: (1) production process review: due to the lack of specific batch number information, the factory retrieved lot; ckdd02-01/ckdd01-01/ckdc12-01 specification and model: 30g x 1/2 "(0.3mm x 13mm) 3 batches of injection needle products.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.(2) retained sample testing: extracted 10 samples from each batch: ckdd02-01/ckdd01-01/ckdc12-01, specification: 30g×1/2"(0.3mm×13mm).Five of these samples each batch were used for testing the lumen patency according to iso7864:2016 4.13 injection needle patency of lumen.A 0.11±0.001 stylet was introduced into the needle lumen, where it freely passed through.Five other retained samples were taken from each of the three batches to connect the luer slip syringe for injection liquid patency test.All the samples were qualified, and no blockage of the needle was found.(3) root cause analysis: based on customer feedback and the analysis of the production process and manufacturing techniques of the injection needle products, it is speculated that the blockage inside the needle lumen may be due to the accumulation of silicone fluid, the adhesive between needle tube or puncture debris, resulting in partial or complete blockage.Further investigation is needed to understand the specific cause of the needle blockage.We recommend the customer to assist by collecting a sample of the clogged needle and sending them back or conducting tests for further analysis.
Event or Problem Description
The customer claims that about 50 needles from their order have been clogged.

• Brand Name: MCKESSON
• Common Device Name: NEEDLE
• 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: 19709367
• Report Number: 3003560965-2024-00065
• Device Sequence Number: 3175976
• 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"
• Device Catalogue Number: 16-N3005
• Device Lot Number: CKDC12-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• 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