MAUDE Adverse Event Report: ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. HENRY SCHEIN INC; HYPODERMIC NEEDLES

Model Number	30G*1/2''
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Review of production process production records of this batch were inspected and no abnormalities were found during production.No changes were made to the raw materials or production process of the product.The product is assembled by an automatic assembly machine equipped with a blockage inspection process, which tests each product individually.Any defective products are automatically rejected.Before each shift, inspectors verify the inspection function, and production is only carried out when the function is confirmed normal.2.Batch sample testing five retained samples of the hypodermic needle with batch no.20240728 and specification 30g 1/2" were selected for testing: 1) three samples were tested for lumen patency in accordance with the requirements of iso 7864:2016, and the test results met the specifications.2) two samples were tested for fluid aspiration and injection to simulate clinical use; all samples were unobstructed without blockage.3.Root cause analysis 1) the blockage may be caused by clinical practice of using the hypodermic needle to puncture medication vials directly for drug preparation and aspiration, where rubber stopper debris generated during puncture clogs the needle lumen.2) the blockage may result from the high viscosity of the clinical medication used.3) the failure of fluid delivery through the needle may be attributed to abnormalities in other supporting infusion devices used clinically.
Event or Problem Description
The customer advised that their clinical staff, including the physician, have reported that the needles seem to be clogged, making it difficult for product to flow through properly during use.

• Brand Name: HENRY SCHEIN INC
• Common Device Name: HYPODERMIC NEEDLES
• 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: 24949209
• Report Number: 3003560965-2026-00011
• Device Sequence Number: 14804222
• Product Code: FMI
• UDI-Device Identifier: 00304040003084
• UDI-Public: 00304040003084
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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''
• Device Lot Number: 20240728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/22/2026
• 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