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

Model Number	20G*19MM
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Blood specimens could not be transferred into blood culture bottles.
Additional Manufacturer Narrative
Production process review: tracing the production process batch records and finished product factory inspection reports of this batch of products, there have been no changes in raw materials and production processes, and the finished product has passed the factory inspection.2.Sample retention testing: batch number: 241118 specification: 20g*19mm blood collection needle, retain 5 samples for testing: 1) appearance inspection shows that all components are undamaged and not detached.2) using 5 simulated clinical collection tests, connect each blood collection needle to a 10kpa water pressure catheter, and collect 5 vacuum collection tubes from each blood collection needle, all of which can collect normally without blockage.3.Cause analysis: the principle of blood collection with a blood collection needle is to use the vacuum negative pressure of the blood collection tube and human blood pressure to draw blood into the blood collection tube (collection tube).The blood collection needle only provides a channel; based on the above sample surveys, it can be used normally, and according to the customer's description, the user is connected to the blood culture bottle for collection, and blood cannot enter the blood culture bottle.It is understood that the blood.The culture bottle cannot be directly connected with ordinary intravenous blood collection needles or syringes.

• Brand Name: MAVERIC MEDICAL LLC
• Common Device Name: BLOOD TRANSFER 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: 23797155
• Report Number: 3003560965-2025-00032
• Device Sequence Number: 12190755
• Product Code: JKA
• UDI-Device Identifier: 10885380182952
• UDI-Public: 10885380182952
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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: 20G*19MM
• Device Lot Number: 241118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 12/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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