MAUDE Adverse Event Report: ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. MAVERIC MEDICAL LLC; BLOOD COLLECTION ADAPTER

Model Number	20G*19MM
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
When using to draw labs from iv, the adapter is causing blood collection tubes to pop off.The tubes feel pressurized and blood sprays on the patient.This is for multiple different blood tubes mainly without gel/medium.Multiple tubes were used before the failure.
Additional Manufacturer Narrative
1.Review of production process: the batch records of the production process and the finished product release inspection records of the above batch were traced.No changes were made to raw materials or production processes.No abnormalities were found during either the production process or finished product inspection process, and the finished product passed the release inspection.Our company has confirmed the hardness requirements for the rubber sleeve with the supplier and requires the supplier to strictly control the hardness of the rubber sleeve.Upon arrival, our company tests the tensile properties and resilience of the rubber sleeve (resilience testing is performed using kdl collection tubes), so as to ensure that the blood collection tube will not be ejected when the rubber sleeve is used with the blood collection adapter.2.Retained sample testing: five retained samples of the blood collection adapter with batch no.: 250728 and specification: 20g*19mm were selected for testing: visual inspection: the surface of the rubber sleeve of the blood collection adapter was smooth, and all components were intact.Simulated clinical blood collection tests were conducted, and no tube ejection was observed in any sample.3.Root cause analysis: no abnormalities were identified based on the above investigation.In clinical use, the blood collection needle must be used with a blood collection tube to complete blood collection.Tube ejection involving the blood collection needle may be attributed to multiple factors, such as the resilience and hardness of the rubber plug of the blood collection needle; the hardness, thickness and clamping force of the rubber plug on the blood collection tube; the position where the puncture needle is inserted into the rubber sleeve of the collection tube, etc.

• Brand Name: MAVERIC MEDICAL LLC
• Common Device Name: BLOOD COLLECTION ADAPTER
• 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: 24870247
• Report Number: 3003560965-2026-00009
• Device Sequence Number: 9877990
• Product Code: KST
• UDI-Device Identifier: 10885380182945
• UDI-Public: 10885380182945
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 04/14/2026

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: 20G*19MM
• Device Lot Number: 250728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/14/2026
• 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