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	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there appears to be a rough/rusty residue on the bevel section of the needle.
Additional Manufacturer Narrative
(1) batch sample testing: according to customer feedback information, (b)(4) needles of sample retention with batch number: ckdd02-01 specification: 30g¡á1/2 "(0.3mm¡á13mm) were selected for relevant testing on october 25, 2024; 1.Use a 10x magnifying glass to inspect the appearance of each needle one by one.The needle tube should be clean and free of foreign objects.Check under 10x magnification, and the needle tip should be sharp, free of burrs,edges and curved hooks.2.Using a universal imaging measurement system, 10 sample needles were extracted and the needle tip was locally magnified 70 times.No rough/rusty residue was found on each needle tip during observation.Please refer to the attached image for details.(2) production process review: according to the batch number, the batch record and finished product inspection report of the production process of this batch of products were traced back, and no changes were found in the production process and production technology of this batch of products, and no such abnormalities were found in the production process and finished product inspection process.(3) cause analysis: no abnormalities were found during the investigation of the sample products and processes mentioned above.

• Brand Name: MCKESSON GLOBAL SOURCING LTD
• 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; wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer Contact: suhua li ; no.758,5th binhai road; wenzhou, zhejiang 32502-5 ; CH 325025
• MDR Report Key: 20649617
• Report Number: 3003560965-2024-00081
• Device Sequence Number: 3102961
• 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): 11/11/2024

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: CKDD02-01
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/11/2024
• 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