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

Model Number	18G×1 1/2" (1.3MM×38MM)
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample retention test: on (b)(6) 2024, (b)(4) samples of the above sample products were selected for batch number: ckdc12-01 specification model: 18g×1 1/2 "(1.3mm×38mm) related tests, specific tests are as follows: 1.Keep (b)(4) samples of the same batch of products, and test the appearance of the hypodermic needle one by one with the aid of a 10x magnifying glass to check that the tip of the needle has no burrs, bent hooks and other abnormal conditions; the above batch all appearance tests were normal.(detection tool: 10x magnifying glass, inspection personnel: (b)(6)).2.(b)(4) retained hypodermic needles of this batch were used for puncture and fragmentation removal test (according to iso7864:2016 appendix b), and (b)(4) bottle stopper hardness was selected for testing to meet the standard requirements (bottle stopper hardness) degree: (b)(4) sauer a-55 sauer a), each bottle stopper is punctured vertically at different positions in the puncture area for 4 times, and after the fourth puncture, the dropped dust in the channel is discharged into the injection bottle by rinsing or a patency device (such as a syringe); (b)(4) piercings (each stopper) x25 stoppers for (b)(4) piercings (b)(4) times of puncture (each hypodermic needle) x25 hypodermic needles, a total of (b)(4) puncture times, the above test results of this batch of puncture debris number is 0 (inspector: liang zhixiang) (2) production process review: according to the batch number, the batch records of the production process of the batch of products and the finished product inspection report are traced.There are no abnormal conditions in the process inspection and finished product inspection, and the raw materials and production technology of the products have not changed.In the iso7864:2016 disposable hypodermic needle standard, there are test instructions for fragmentation drop items in appendix b, but the standard does not measure the amount of fragmentation drop of hypodermic needle products (since iso 7864:2016 appendix b has a test method for puncture debris drop, there is no requirement for the number of debris drop indicators, for zhejiang instruments, please note 20192140120 appendix 3.1.8 b/ iso 7864:2016 appendix b puncture drop test methods are basically the same, so our company refers to the requirements of 2.1.8 puncture drop (index) in zhexiezhuzhun standard 20192140120 (as shown below), and the requirement for dispensing hypodermic needles is that (b)(4) puncture drops should not exceed 3).The hypodermic needle produced by our company is mainly used for human puncture injection (the tip of the hypodermic needle used for human puncture injection will be sharp, which will reduce the pain felt by patients during the puncture process).If it is used for puncture bottle stopper, there will be a risk of falling fragmentations.If it is used for puncture bottle stopper to draw medicine liquid, it is recommended to use the hypodermic needle for dispensing medicine, which can more effectively avoid falling fragmentations.
Event or Problem Description
It was reported that the needles have a coring issue.

• Brand Name: MCKESSON
• Common Device Name: 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: 20576679
• Report Number: 3003560965-2024-00077
• Device Sequence Number: 8170939
• Product Code: FMI
• UDI-Device Identifier: 10612479206554
• UDI-Public: 10612479206554
• 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): 10/31/2024

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
• Device Model Number: 18G×1 1/2" (1.3MM×38MM)
• Device Catalogue Number: 16-N18105
• Device Lot Number: CKDC12-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/31/2024
• 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