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

Model Number	30G*11"
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports that while using either the 30ga needle(hs (b)(6)) they were clogging when mixing different types of drugs.These included dexamethasone, methylprednisolone, marcaine and lidocaine.This was for joint injections, plantar fascia.The amounts would be either of the following: a.2cc lidocaine,.5cc dexamethasone,.5cc methylprednisolone, b.2cc marcaine,.5cc dexamethasone,.5cc methylprednisolone, c.1cc marcaine,.25cc dexamethasone,.25cc methylprednisolone.This happened with multiple patients over the last month, no specifics would be provided.No patients were harmed or required any medical attention.There was a delay as they had to use three different needles on their patients, with multiple patient occurring with multiple doctors in their practice.
Additional Manufacturer Narrative
Based on customer feedback and a review of relevant literature by our company, in vitro studies have found that significant crystallization occurs with various clinically common mixed regimens.Methylprednisolone used for intra-articular injection is usually a suspension (e.G., methylprednisolone acetate), in which the drug is suspended in liquid as microcrystals rather than being completely dissolved.When such a suspension is mixed with other drugs,especially those with complex compositions,its physical stability may be compromised, causing microcrystals to aggregate into visible precipitates or flocs, which can result in needle blockage.In addition, although dexamethasone is generally a solution and relatively stable, studies have shown that it may also react or form precipitates when mixed with other drugs.Cases of this compliant associated with the mixing of dexamethasone and other drugs have been documented in the literature.Based on the above investigation, this complaint was caused by the physical and chemical incompatibility between the mixed drugs.

• 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: linjuan yao ; no 658., gao chao rd.; jiading shanghai, shanghai 20180-3 ; CH 201803
• MDR Report Key: 24625509
• Report Number: 3003560965-2026-00004
• Device Sequence Number: 21004836
• Product Code: FMI
• UDI-Device Identifier: 00304040003091
• UDI-Public: 00304040003091
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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*11"
• Device Lot Number: 20241120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown