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

Model Number	21G×1 INCH
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer experienced issues with the blood collection needle detaching from the plastic hub during use.They had to manually hold the needle in place to prevent it from popping off.This problem began after switching to mckesson brand needles, whereas they did not haveissues with their previous needles.
Additional Manufacturer Narrative
(1) batch sample testing: according to customer feedback, batch number: ckdd05-01, ckdd04-01 specification: 21g× 1-inch samples were collected from the above two batches of (b)(4) blood collection needles for simulated clinical blood collection test.Each blood collection needle was connected to (b)(4) collection tubes to complete the collection.No abnormal situation of bomb tubes occurred during the test (see the videos in annex 1 and 2 for details).(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 cartridges was found in the retained samples of the blood sampling needle products in this batch.Blood collection needle products need to be used together with the collection tube in clinical use to complete blood collection.The elastic tube of the blood collection needle reported by the customer may be related to various factors, such as the elastic tube caused by too small friction between the rubber sleeve of the blood collection needle product (collection end needle silicification) and the elastic tube, and the hardness, thickness and other aspects of the rubber plug on the collection tube may lead to the abnormal phenomenon of the collection tube bouncing back.

• Brand Name: MCKESSON
• Common Device Name: 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: 20576670
• Report Number: 3003560965-2024-00080
• Device Sequence Number: 18185224
• Product Code: JKA
• UDI-Device Identifier: 20612479244492
• UDI-Public: 20612479244492
• 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): 10/31/2024

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 INCH
• Device Catalogue Number: 16-NBC21G1
• Device Lot Number: CKDD05-01, CKDD04-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown