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

Model Number	27G*1 1/4''
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports that every single one they use is getting clogged.They use kenalog, lidocaine and marcaine.It happened to 14 of the patients with two different doctors.All of the procedures are on the feet, ankle, interspacsm, nueroma, heel trigger points and sinus tarsi injections.No patients were harmed or required any medical attention.It happened on (b)(6) 2026.No patient specifics provided.No photos available.
Additional Manufacturer Narrative
According to customer feedback and our literature review, kenalog is a suspension rather than a fully dissolved solution.This means the product contains fine particles.If the drug is not adequately shaken before use, the drug particles will settle and aggregate at the bottom of the vial.During aspiration, these aggregated large particles enter the syringe and can easily cause needle blockage.Lidocaine and marcaine are generally compatible.However, when kenalog is mixed with them, improper mixing order or prolonged standing after mixing may cause kenalog particles to flocculate due to minor changes in osmotic pressure or ph, forming larger clumps and resulting in syringe blockage.In addition, the injection sites are concentrated in dense connective tissue areas such as the ankle, intermetatarsal space, and neuroma, which inherently have high resistance.When the drug contains suspended particles, the particles are more likely to be compressed and accumulated at the needle bevel as the needle passes through dense tissue, creating a wedging effect that leads to blockage.Based on the above investigation, this complaint was most likely caused by drug particles or particles/flocs formed after mixing, resulting in syringe/needle blockage.

• 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: 24631250
• Report Number: 3003560965-2026-00005
• Device Sequence Number: 21086359
• Product Code: FMI
• UDI-Device Identifier: 00304040002940
• UDI-Public: 00304040002940
• 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: 27G*1 1/4''
• Device Lot Number: 20250721
• 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
• 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