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	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(1) retest of retained samples: on (b)(6) 2024, 20 retained samples of batch no.: ckdc10-01 specification: 18g×1 1/2 "(1.3mm×38mm) were selected for appearance test, and the adhesive of the hypodermic needle products in this batch were full without abnormal condition; and 10 pieces were selected to test the rigidity and toughness.Another 10 pieces were selected for firmness test.According to iso 7864:2016 "requirements and test methods for single-use sterile hypodermic needles", the load weight of 69n was found, and no needles and needle bases fell off.The test results of this batch of hypodermic needles all met the standard requirements (for details, see the attachment and the hypodermic needle test diagram and table in attachment 1).Hypodermic needle (needle) rigidity tester hypodermic needle (needle) toughness tester, weight tester: chen liuxiang liang zhixiang).(2) production process review: according to the batch number, the batch records of the production process of this batch of products and the finished product inspection report are traced.The adhesive of this batch of hypodermic needle products is full, the rigidity and toughness are in line with the standard requirements, and the production process and production raw materials are not changed.(3) through the relevant sample retention test, production process review and production site verification, this batch of hypodermic needle products did not find that the needle tubes lacked adhesives, the firmness did not meet the requirements, or the needle tubes were defective due to double cutting on the surface of the needle tubes.The company made the following possibility analysis on the situation of the fracture of the needle tubes as reported by the customer: a: less adhesive between the needle and the needle holder causes the needle to fall off from the needle holder: in the process of hypodermic needle assembly, an online testing device is equipped to detect the amount of adhesive.If there are defective products with little or no adhesive, the equipment will automatically remove the defective products.In addition, the first check of the adhesion between the needle tube and the needle holder will be carried out in each shift during the process, and the finished product inspection will also conduct random checks on this item, so the possibility of falling off is almost non-existent.This possibility can be ruled out.B: the syringe tube is broken during use: improper use of the product during clinical use leads to needle breakage, according to iso 7864:2016 "requirements and test methods for single-use sterile hypodermic needles" quoting iso 9626:2016 "stainless steel needles for the manufacture of medical devices - requirements and test methods" in appendix c 5.9 of the toughness test, the requirement for the curvature of the needle is (25±1) ° with normal wall thickness.Thin-wall needle bending (20±1) °, ultra-thin-wall needle bending (15±1) °, according to the requirements of 20 times back and forth bending test, the needle should not break.If bending exceeds the standard requirements, the probability of breakage of the needle will increase.Although the user of the product is usually a trained health care worker with the relevant expertise in proper product use, the possibility of breakage of the needle due to improper use cannot be completely ruled out.C: our company has carried out a risk analysis for the problem of needle breakage in the early stage.This incident is an accidental event.The sales volume of this batch is 480,000, and this is the first time to feedback such a problem of needle breakage.The total sales volume of this type of sterile hypodermic needle in 2023 to the customer is 37 million, and through its risk analysis is acceptable.Since the customer has not provided specific defective product or needle fracture surface diagram for analysis, our company suggests that the customer help collect the defective product sample and send back or provide high-definition images of the specific needle and needle base separation of the defective product (mainly the needle fracture site).According to the fracture surface of the needle, it can be determined that the needle and needle base are separated due to the falling off between the needle and the glue.Whether it is due to external force that leads to the fracture of the needle tube, our company will compare and analyze the relevant situation disposition and follow-up actions (1) our company attaches great importance to it.Please arrange to remove the broken needle as soon as possible to avoid harm to patients.(2) explain the situation in writing to the customer; (3) it is suggested that the customer can help collect the defective product sample and send back or provide high-definition images of the specific needle tube and needle base separation of the defective product (mainly the fracture of the needle tube).
Event or Problem Description
The customer claims that the needles are breaking in the patient.

• 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: 20320703
• Report Number: 3003560965-2024-00075
• Device Sequence Number: 15361148
• 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): 09/27/2024

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: CKDC10-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/27/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown