MAUDE Adverse Event Report: ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. MCKESSON; SAFETY BLOOD COLLECTION NEEDLES

Model Number	21G×1 1/4INCH
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(1) batch inspection: on march 27, 2024, for batch number: ckdc10-01, specification and model: 21g×1 1/4 inch, based on customer feedback information, 15 retained samples were selected for appearance testing.The needle tubes were straight without any abnormalities such as bending; each of the 5 products can be stimulated and shielded by pressing the desktop and thumb respectively (see appendix 1.2 video for details); then, 5 samples were selected for safety device excitation force testing.The results of the safety device excitation force test for the 5 sample products were 1.59-2.23n, and the safety device destructive force was 9.12-11.58n, both of which met the standard requirements.No abnormal situations were found in the above tests of the safety blood collection needle.(2) production process review: based on the batch number traceability, batch number: ckdc10-01 specification and model: 21g×1 1/4 inch.The production process batch records and finished product factory inspection reports show that there have been no changes in the production process and production flow.The excitation force test results in the production process inspection records also meet the standard requirements (2) production process review: based on the batch number traceability, batch number: ckdc10-01 specification and model: 21g×1 1/4 inch.The production process batch records and finished product factory inspection reports show that there have been no changes in the production process and production flow.The excitation force test results in the production process inspection records also meet the standard requirements.(3) sample testing: on (b)(6) 2024, we received 20 unopened blood collection needles from the customer.Batch number: ckdc10-01, specification and model: 21g×1 1/4 inch, safe blood collection needle product.We used 5 needles each and activated them by pressing the desktop and thumb.The products were able to activate and shield the needle tip normally; and 5 samples were selected for safety device excitation force testing.The results of the safety device excitation force test for the 5 sample products were 1.99-2.21n, and the safety device destructive force was 9.72-11.15n, all of which met the standard requirements, and no abnormal situations were found in the above tests of the safety blood collection needle.
Event or Problem Description
The safety mechanism on these needles has been problematic, with complaints about it tilting to the side and leaving the needle exposed.Technicians have expressed concerns about accidentally getting injured and have resorted to not activating the mechanism.Additionally, the safety mechanism does not open smoothly or fully, causing inconvenience during blood drawing; also, it has been observed that it can push off some of the larger tubes off the needle while they filled with blood.

• Brand Name: MCKESSON
• Common Device Name: SAFETY BLOOD COLLECTION NEEDLES
• 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: 21132171
• Report Number: 3003560965-2024-00085
• Device Sequence Number: 20540371
• Product Code: JKA
• UDI-Device Identifier: 20612479244331
• UDI-Public: 20612479244331
• 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): 01/09/2025

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: 21G×1 1/4INCH
• Device Lot Number: CKDC10-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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