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

Model Number	30G*1/2''
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Production process review: it was verified that the raw materials and production process of this batch of hypodermic needles had not been changed, no abnormalities occurred during the production process, and the finished products passed the ex-factory inspection.2.Retained sample inspection: 100 retained samples of hypodermic needles with batch no.: 20250601 and specification: 30g*1/2" were randomly selected for inspection.No needle-penetrating-protective cap phenomenon was found in any sample.3.Root cause analysis:due to limited information provided by the customer, it cannot be determined whether the needle penetrated the protective cap before use or during re-sheathing after drug preparation.Our preliminary analysis of possible causes is as follows: if the needle penetrating the protective cap was found upon opening the package, it may be caused by an individual protective cap not vertically coming down from the chute and being caught by the needle tip, resulting in the needle tip penetrating the protective cap during the protective cap crimping process.During the blister packaging process, the full-inspection operator failed to detect and reject the defective product in time due to the inspection environment and other conditions, leading to its outflow.If the problem was found after use, it may be caused by improper operation during re-sheathing after clinical drug preparation.After use, the needle should be directly disposed of in a sharps container.Re-sheathing the hypodermic needle carries the risk of needle penetration through the protective cap, and such operation (re-sheathing) does not comply with the requirements for disposal of used medical devices.
Event or Problem Description
The customer is getting poked through the cap.Left a voice message for ivril, the nurse to answer additional questions about this event.
Additional Manufacturer Narrative
1.Production process review: it was verified that the raw materials and production process of this batch of hypodermic needles had not been changed, no abnormalities occurred during the production process, and the finished products passed the ex-factory inspection.2.Retained sample inspection: 100 retained samples of hypodermic needles with batch no.: 20250601 and specification: 30g*1/2" were randomly selected for inspection.No needle-penetrating-protective cap phenomenon was found in any sample.3.Root cause analysis:due to limited information provided by the customer, it cannot be determined whether the needle penetrated the protective cap before use or during re-sheathing after drug preparation.Our preliminary analysis of possible causes is as follows: if the needle penetrating the protective cap was found upon opening the package, it may be caused by an individual protective cap not vertically coming down from the chute and being caught by the needle tip, resulting in the needle tip penetrating the protective cap during the protective cap crimping process.During the blister packaging process, the full-inspection operator failed to detect and reject the defective product in time due to the inspection environment and other conditions, leading to its outflow.If the problem was found after use, it may be caused by improper operation during re-sheathing after clinical drug preparation.After use, the needle should be directly disposed of in a sharps container.Re-sheathing the hypodermic needle carries the risk of needle penetration through the protective cap, and such operation (re-sheathing) does not comply with the requirements for disposal of used medical devices.
Event or Problem Description
The customer is getting poked through the cap.Left a voice message for ivril, the nurse to answer additional questions about this event.

• 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: 24740492
• Report Number: 3003560965-2026-00007
• Device Sequence Number: 18452268
• Product Code: FMI
• UDI-Device Identifier: 00304040003084
• UDI-Public: 00304040003084
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: 20250601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement 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