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

Catalog Number	16-N3005
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of customer complaint, relevant departments were organized for the investigation, investigation results are provided below: on (b)(6) 2024 5 pcs of gauge 30g*1/2" from lot no.Ckdc10-01 were sampled from retained products for patency of lumen test as per iso 7864:2016 requirements using a stylet of 0.11 outer diameter, which meet the standard.5 pcs were tested for simulated injection fluid preparation when assembled with luer slip syringe, no abnormality was found.And after reviewing of product records and finished product inspection report, no abnormality was found related to the production technique or process.Based on the abovementioned investigations, this case is rare and since no exact product was returned, it is suggested to send back the concerned product for further investigation.Detailed internal report (b)(4) could be provided upon request.
Event or Problem Description
The customer claims that the needles are not dispensing medication properly, the needles seemed to be clogged.

• Brand Name: MCKESSON
• 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: 19349111
• Report Number: 3003560965-2024-00007
• Device Sequence Number: 7280722
• 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): 05/18/2024

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 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: 05/06/2024
• Initial Report FDA Received Date: 05/20/2024
• 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