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

Model Number	22G*1 1/2''(0.7MM*38MM)
Medical Device Problem Codes	Complete Blockage (1094); Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the solution wouldn't come out of needle when pushed.After replacing the syringe with no improvement, it was determined that the problem originated with the needle.
Additional Manufacturer Narrative
1.Production process review: the production records for this batch were examined, and no abnormalities were found in the production process.There have been no changes in the raw materials or production methods.2.Batch sample testing: 15 retained samples from this batch were selected for testing 1).Ten samples were tested for lumen patency according to the requirements of iso7864-2016, using a 0.35mm guide pin inserted into the needle tube.The guide pin was able to pass freely through each tube.2).Five samples were used to simulate clinical use by performing liquid extraction and injection tests.The test results showed that all samples exhibited free flow with no blockages.3.Cause analysis: it is possible that during clinical use of injection needles for preparing medication, debris from puncturing the rubber stopper clogs the needle tube.Our injection needle is primarily designed for subcutaneous injections in humans and is not recommended for directly drawing or adding medication.Since the defective needle was not returned, preliminary analysis suggests that the blockage in the needle lumen was likely caused by debris generated from puncturing the vial's stopper during liquid extraction in clinical settings.If clinical use requires drawing or mixing medication, it is recommended to use our dedicated medication mixing needle to effectively prevent debris formation.
Event or Problem Description
It was reported by the customer that the solution wouldn't come out of needle when pushed.After replacing the syringe with no improvement, it was determined that the problem originated with the needle.
Additional Manufacturer Narrative
1.Production process review: the production records for this batch were examined, and no abnormalities were found in the production process.There have been no changes in the raw materials or production methods.2.Batch sample testing: 15 retained samples from this batch were selected for testing 1).Ten samples were tested for lumen patency according to the requirements of iso7864-2016, using a 0.35mm stylet inserted into the needle tube.The stylet was able to pass freely through each tube.2).Five samples were used to simulate clinical use by performing liquid extraction and injection tests.The test results showed that all samples exhibited free flow with no blockages.3.Sample testing: received 15 unopened samples with batch number ckdc12-01 and specification 22g*1 1/2 "(0.7mm * 38mm) from the customer on april 11, 2025.Relevant testing was conducted on the samples 1) inspection of the patency of the needle tube lumen: 5 needles were extracted and inserted into the needle tube lumen using a 0.35mm stylet according to the requirements of iso7864-2016 standard.The through needles were able to pass freely and fall off, and all samples were qualified after inspection.2) simulated clinical use for liquid extraction and injection testing: connect the remaining 10 syringes to simulate clinical use for liquid extraction and injection testing.After testing, all were found to be unobstructed.Cause analysis: it is possible that during clinical use of hypodermic needles for preparing medication, debris from puncturing the rubber stopper clogs the needle tube.Our injection needle is primarily designed for subcutaneous injections in humans and is not recommended for directly drawing or adding medication.Since the defective needle was not returned, preliminary analysis suggests that the blockage in the needle lumen was likely caused by debris generated from puncturing the vial's stopper during liquid extraction in clinical settings.If clinical use requires drawing or mixing medication, it is recommended to use our dedicated medication mixing needle to effectively prevent debris formation.

• Brand Name: MCKESSON
• Common Device Name: HYPODERMIC 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; longwan district; wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer Contact: suhua li ; no.758,5th binhai road; wenzhou, zhejiang 32502-5 ; CH 325025
• MDR Report Key: 21803356
• Report Number: 3003560965-2025-00012
• Device Sequence Number: 8974800
• Product Code: FMI
• UDI-Device Identifier: 10612479206677
• UDI-Public: 10612479206677
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: 22G*1 1/2''(0.7MM*38MM)
• Device Lot Number: CKDC12-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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