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

Model Number	22G*1.5''
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Production process review: the production records of the batch were examined, and no abnormalities were found in the production process.The raw materials and manufacturing procedures remained unchanged, and the finished products passed the factory inspection.The product is assembled using an automatic assembly machine, which applies adhesive to the needle tubes automatically.The assembly machine is equipped with a detection device to monitor the adhesive application, enabling real-time rejection of products with insufficient adhesive.During production, the adhesive strength is inspected at the beginning of each shift.2.Batch sample inspection: a sample of 10 retained units from batch number: 240520 (specification: 22g*1.5'') was tested as follows: visual inspection: the adhesive between all needle tubes and hubs appeared fully applied with no abnormalities.5 pcs were tested for adhesive strength between the needle hub and tube according to iso 7864:2016, with no instances of detachment observed.Another 5 pcs underwent simulated clinical injection testing, and no needle tube dislodgement occurred.3.Root cause analysis: based on the above investigation, the possible cause is insufficient adhesive leading to weak bonding.However, since no defective samples, related photos, or videos were provided, the exact root cause could not be confirmed.
Event or Problem Description
The customer reported that when using our 22g needles connected to a bd 30ml syringe, the needle retracted into the hub during use.The issue may be related to bonding, the needle might not have been securely bonded, causing it to retract when subjected to forward force.

• 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: 22912007
• Report Number: 3003560965-2025-00022
• Device Sequence Number: 18437765
• Product Code: FMI
• UDI-Device Identifier: 30080196305531
• UDI-Public: 30080196305531
• Combination Product (Y/N): N
• 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): 08/28/2025

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
• Device Model Number: 22G*1.5''
• Device Catalogue Number: SYR100227
• Device Lot Number: 240520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/28/2025
• 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