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

Model Number	21G×1 1/4 INCH
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(1) batch test: sampled on august 16, 2024, batch number: ckdd04-01, specification: according to customer feedback, 10 retained samples of 21g× 11/4 inch were extracted from this batch for simulated clinical blood collection test.Each blood collection needle was connected to 5 collection tubes respectively to complete the collection.No abnormal situation of bomb tubes occurred during the test (tester: (b)(6)).(2) production process review: according to the batch number, trace the batch records of the production process and the finished product inspection report, and no such abnormal situation was found in the production process and the finished product inspection process; through the testing of the batch samples and the tracing of the production process, no abnormal situation of such bomb tubes was found in the retained samples of the batch products.Since no real sample or relevant feedback video has been collected for analysis this time, it is suggested that the customer help collect more information to help our company further analysis.
Event or Problem Description
The customer claims that the vacutainer tubes pop off of the needle during the drawing process and it has caused them to have to stick patients twice.

• Brand Name: MCKESSON
• Common Device Name: SAFETY BLOOD COLLECTION NEEDLE
• 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: 20320702
• Report Number: 3003560965-2024-00073
• Device Sequence Number: 15499690
• 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): 09/27/2024

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 Model Number: 21G×1 1/4 INCH
• Device Catalogue Number: 16-NBC21GS
• Device Lot Number: CKDD04-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/27/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown