MAUDE Adverse Event Report: ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD MCKESSON GLOBAL SOURCING LTD; NEEDLES

Model Number	25G*1 1/2''(0.5MM*38MM)
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Review of production process: the production records of the batch were examined, and no abnormalities were found in the production process.There were no changes in the raw materials or production techniques used for the product.2.Batch sample testing: on (b)(6) 2025, 10 samples from the retained batch no.: ckdc10-01, specification: 25g*1 1/2'' (0.5mm*38mm) were tested as follows: 1) five samples were tested for lumen patency in accordance with iso 7864: 2016 standards, and the results met the requirements (see attachment 1).2) the remaining five samples underwent simulated clinical use for aspiration and injection testing, with all samples functioning smoothly and no blockages observed.3.Sample testing: on (b)(6) 2025, we received 10 new and unused samples from the customer with batch number ckdc10-01 and specification 25g *1 1/2 "(0.5mm*38mm).We conducted relevant testing on the samples 1) according to the requirements of iso7864-2016 standard, use 5pcs 0.230mm stylet to insert the inner cavity of the needle tube, and the stylet can freely pass through and fall off.2) five simulated clinical samples were used for suction and injection drug testing, and all were found to be unobstructed.3.Root cause analysis: the issue may stem from clinical practices where hypodermic needles are directly used to puncture medication vials for drug preparation.During this process, coring from the rubber stopper may clog the needle lumen.It is important to note that this particular hypodermic needles product is primarily designed for subcutaneous human injection and is not recommended for direct drug aspiration or preparation.If such use is required in clinical settings, we advise using dispensing needles, which are specifically designed to minimize coring and ensure smooth operation.
Event or Problem Description
It was reported that the needle is not allowing the medication to pass through; they further explained that whenever they try and push omnipa que or depomedrol through the needle, it would not inject, mainly for caudal epidurals.

• Brand Name: MCKESSON GLOBAL SOURCING LTD
• Common Device Name: 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: 22911999
• Report Number: 3003560965-2025-00014
• Device Sequence Number: 15731048
• Product Code: FMI
• UDI-Device Identifier: 10612479206769
• UDI-Public: 10612479206769
• Combination Product (Y/N): N
• PMA/510(K) Number: K112057
• 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): 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: 25G*1 1/2''(0.5MM*38MM)
• Device Lot Number: CKDC10-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2025
• Initial 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown