MAUDE Adverse Event Report: ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD MCKESSON GLOBAL SOURCING LTD; SAFETY BLOOD COLLECTION NEEDLES WITH TUBE HOLDER

Model Number	21G*1 1/4'' (0.80MM*31.75MM)
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the product they received are defective.They require excessive pressure to keep the vacutainer tube in, which causes discomfort (hurt the veins).
Additional Manufacturer Narrative
1.Batch test: february 8, 2025 sampling batch number: ckdd02-01 specification: 21g×1 1/4 in (0.80mm×31.75mm) safety blood collection needle 10 tips appearance test.A.Appearance inspection of the needle tip after removing the rubber cover from the puncture end of the needle: five batch safety blood collection needles were randomly selected, and the tips of the rubber cover removed from the puncture end of the safety blood collection needle were placed under 10 times the magnification for inspection.Needle tip sharp, no burr, burr and curved hook, etc.Examination results: all qualified.B.The 5 safety blood collection needles were used to simulate the clinical blood sample collection test, and no abnormal situation was found that a large pressure could not be applied to puncture.2.Production process review: according to the batch number, the batch record and the finished product factory inspection report were traced back to the production process of this batch of products, and no abnormal phenomena were found.No changes were found in the raw materials and production process of this batch of products.3.Cause analysis: according to the above investigation of sample retention, our company's safety blood collection needle products were observed under a magnification of 10 times, the tip of the needle was sharp, without burr, curved hook and other abnormalities, and no abnormalities were found in simulated clinical blood sample collection.
Additional Manufacturer Narrative
1.Batch test: february 8, 2025 sampling batch number: ckdd02-01 specification: 21g* 11/4'' (0.80mm*31.75mm) 10 of safety blood collection needle tip appearance test.A.Appearance inspection of the needle tip after removing the rubber cover from the puncture end of the needle: five batch safety blood collection needles were randomly selected, and the tips of the rubber cover removed from the puncture end of the safety blood collection needle were placed under 10 times the magnification for inspection.Needle tip sharp, no burr, burr and curved hook, etc.Examination results: all qualified.B.The 5 safety blood collection needles were used to simulate the clinical blood sample collection test, and no abnormal situation was found that a large pressure could not be applied to puncture.2.Production process review: according to the batch number, the batch record and the finished product factory inspection report were traced back to the production process of this batch of products, and no abnormal phenomena were found.No changes were found in the raw materials and production process of this batch of products.3.Testing of sample from user : on march 31, 2025, received 6 unopened products from the customer with the following details: batch no.: ckdd02-01 | specifications: 21g*1 1/4'' (0.80mm*31.75mm).Testing was conducted as follows: (1)the protective sleeve on the puncture end was removed, and the needle tip was examined under 10x magnification.The tip was sharp, with no burrs, flashes, or hooked deformities.(2)simulated clinical blood collection tests were performed, and blood can be collected smoothly without any puncture abnormalities.4.Cause analysis: according to the above investigation of sample retention and the testing of sample from user, our company's safety blood collection needle products were observed under a magnification of 10 times, the tip of the needle was sharp, without burr, curved hook and other abnormalities, and no abnormalities were found in simulated clinical blood sample collection.
Event or Problem Description
The customer reported that the product they received are defective.They require excessive pressure to keep the vacutainer tube in, which causes discomfort (hurt the veins).

• Brand Name: MCKESSON GLOBAL SOURCING LTD
• Common Device Name: SAFETY BLOOD COLLECTION NEEDLES WITH TUBE HOLDER
• 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: 21407524
• Report Number: 3003560965-2025-00003
• Device Sequence Number: 13106936
• Product Code: JKA
• UDI-Device Identifier: 10612479244389
• UDI-Public: 10612479244389
• 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,Followup
• 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: 21G*1 1/4'' (0.80MM*31.75MM)
• Device Lot Number: CKDD02-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 08/28/2025
• 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