MAUDE Adverse Event Report: ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD MEDLINE INDUSTRIES,LP; LUER LOCK ACCESS DEVICE

Model Number	0.9*19RWSB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The luer lock was broken when the user collected the blood.
Additional Manufacturer Narrative
Production process investigation: the batch production records and finished product inspection reports were reviewed, with no abnormalities detected during production.The finished product test results were compliant.The product was assembled using an automatic assembly machine, which includes a blockage and leakage inspection step to examine each individual product.Any defective items are automatically rejected.After needle assembly, the product is transferred to another assembly machine for the attachment of the needle holder.Batch sample testing: sample tested: batch no.220916, specification: 0.9*19 rwsb (25 retained samples of the blood collecting needles).Appearance inspection: no abnormalities such as cracking or crushing were observed on the needle hub surface.Torque force test: 5 retained samples were tested, and all results were compliant.Lipid resistance test: 15 retained samples were tested using three commonly used clinical disinfectant solutions (alcohol-based disinfectant, iodophor disinfectant, and isopropanol disinfectant), with 5 samples tested per solution.No cracking occurred.(refer to attachment 1 for the retained sample test report.) simulated clinical blood collection test: 5 samples were tested, and no cracking or detachment was observed.Root cause analysis: based on the above investigation, the preliminary possible causes are: damage during transportation: rough handling may have caused cracking or damage to the needle hub.Improper assembly with needle holder: during machine setup, if adjustments were not fully optimized, the needle hub could have been over-tightened and cracked, and the defect may not have been detected and rejected during full inspection.Improper clinical operation: the needle hub may have been accidentally over-tightened or cracked during connection with other components in clinical use.Chemical reaction with disinfectant solutions: the disinfectant solutions used clinically may have caused a chemical reaction leading to needle hub cracking.

• Brand Name: MEDLINE INDUSTRIES,LP
• Common Device Name: LUER LOCK ACCESS DEVICE
• 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: 22911997
• Report Number: 3003560965-2025-00020
• Device Sequence Number: 21109839
• Product Code: JKA
• UDI-Device Identifier: 10193489006070
• UDI-Public: 10193489006070
• Combination Product (Y/N): N
• PMA/510(K) Number: K172763
• 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
• Operator of Device: Health Professional
• Device Model Number: 0.9*19RWSB
• Device Catalogue Number: ACSD
• Device Lot Number: 220916
• 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
• Date Device Manufactured: 09/16/2022
• 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