MAUDE Adverse Event Report: ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. HENRY SCHEIN; SINGLE USE SYRINGES

Model Number	1ML LUER SLIP
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer advised that the syringes are defective and they get stuck when using.
Additional Manufacturer Narrative
Upon receiving customer feedback regarding the " the customer complained that the syringes are defective and they get stuck when using," our company promptly organized quality control, production, and related personnel to investigate the situation.Specific details are as follows: production process review: upon tracing back the production process and finished product inspection reports of the batch through the batch number, no abnormal phenomenon was found, and the raw materials and production process of the batch of products were not changed.(2) retained sample testing: on june 7, 2024, 10 samples of batch number: 20210910, specification and model: 1ml were taken from this batch of reserved products.Normal visual inspection was conducted on the appearance, and the inspection results showed that all components of the syringe were defect free and there were no abnormal situations.Using this batch of 10 syringe products to simulate clinical assembly of injection needle products for liquid extraction testing, the test results were all able to extract the liquid normally without any abnormal situations such as jamming or leakage (see attachment 1 video).And conduct positive and negative pressure tests, and the test results are all qualified (testing instrument: syringe body tightness positive pressure tester, syringe body tightness negative pressure tester, tested by: zhang qiuyu).(3) root cause analysis: based on customer feedback and the analysis of the production process and manufacturing techniques of the syringes, it is speculated that there is a defect in the conical injection sleeve of the syringe product or violent loading and unloading caused damage to the outer conical components during the transportation, resulting in gear jamming.We recommend the customer to assist by collecting a sample of the syringes and clinical use of the stuck video for further analysis.

• Brand Name: HENRY SCHEIN
• Common Device Name: SINGLE USE SYRINGES
• Manufacturer (Section D): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758, 5th binhai road; longwan district; wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer (Section G): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758, 5th binhai road; longwan district; wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer Contact: kim chi ; no. 758, 5th binhai road; longwan district; wenzhou, zhejiang 32502-5 ; CH 325025
• MDR Report Key: 19709385
• Report Number: 3003560965-2024-00067
• Device Sequence Number: 3136768
• Product Code: FMF
• UDI-Device Identifier: 10304040134174
• UDI-Public: 10304040134174
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

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 Expiration Date: 09/09/2026
• Device Model Number: 1ML LUER SLIP
• Device Catalogue Number: 570-2121
• Device Lot Number: 20210910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 07/10/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown