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

Model Number	25G*1.5''(38MM)
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The needles are clogging with the injections.Causing an issue with completing the injection, unable and need to re- stick the patient.
Additional Manufacturer Narrative
1.Production process review: based on the batch number, the production process batch records and finished product inspection reports of this batch of products were traced, and no such abnormal situations were found during the production process and finished product inspection process.2.Sample retention testing: 10 samples from lot: 250419 25g*1.5''(38mm) retention samples and conduct the following tests: 1) five samples were taken for retention, and the needle tubes were tested for patency according to the requirements of iso7864-2016 (e) standard.After testing, all needle tubes were found to be unobstructed and no blockage was found.2) another 5 samples were taken to simulate clinical use for suctioning medication, and after testing, all the needle tubes were also unobstructed and unobstructed 3.Cause analysis: 1) production process analysis: during the production process, our company's needle tubes undergo automatic ventilation testing on each tube.If any defective products are found to be blocked, they will be automatically removed by the equipment; at the same time, our inspectors conduct random checks on the produced needle tubes every 4 hours and conduct special inspections for blockages.Therefore, the probability of needle tube blockages in our company is relatively low.2) analysis of usage process: based on our company's past market feedback experience, it is inferred that it may be due to the accidental detachment of rubber particles from the bottle stopper of the medicine bottle during the dispensing process of the needle tube, which blocked the needle tube.Due to the fact that our product is suitable for subcutaneous injection in the human body and is not directly used for drug dispensing and dosing, it is recommended to use a dispensing needle if medication is needed in clinical practice.3) it is also possible that the drugs used in clinical practice are too viscous, leading to the phenomenon of needle blockage.4) it may be due to abnormalities in the clinical combination with other infusion products, resulting in the inability of the needle to inject normally.

• Brand Name: MEDLINE INDUSTRIES,LP
• 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; wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer Contact: suhua li ; no.758,5th binhai road; wenzhou, zhejiang 32502-5 ; CH 325025
• MDR Report Key: 23540470
• Report Number: 3003560965-2025-00031
• Device Sequence Number: 21153246
• Product Code: FMI
• UDI-Device Identifier: 40080196305576
• UDI-Public: 40080196305576
• Combination Product (Y/N): N
• PMA/510(K) Number: K233037
• 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): 11/13/2025

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 Expiration Date: 04/19/2025
• Device Model Number: 25G*1.5''(38MM)
• Device Lot Number: 250419
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2025
• 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