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

Catalog Number	16-N22105
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of customer feedback, relevant personnel were organized for the investigation, details are provided below: on 2024.05.13, 10 pcs of concerned products 22g*1 1/2" from lot no.Ckdc08-01 were sampled from retained samples for needle point inspection and penetration force test.1.Needle point inspection: observation under 10 times magnifier for needle point inspection, the needle point shall appear sharp, free from burrs, hooks and feather edges, all results were qualified.2.Penetration force test: using the 10 sampled products to conduct penetration force tests, the penetration force requirement is from domestic hypodermic needle requirement which sets the value for gauge 0.7 as 0.85 at maximum, and the results were ranging from 0.424 to 0.489, which were also qualified.After review of production records, no abnormality was found related to production technique and raw material.Since the intended purpose for this product is mainly used for hypodermic injection, which aims to reduce the pain during puncture process and in case this product is used for medicinal fluid preparation, it may lead to needle point damage, it is suggested to use the specific dispensing needle instead of this product.There are several factors that may cause the needle point to become dull including: a.The needle point is damaged during cap removal, remember to remove the cap in parallel with the needle tube to avoid potential damage to the needle point.B.The concerned product is mainly used for hypodermic injection, take care to avoid the needle point contact the vial bottom or vial walls during injection preparation.C.It is not recommended to use this product for vial puncture as the needle point may become dull during vial penetration or come into contact with vial wall.Relevant internal report (b)(4) could be provided upon requests with necessary attachments.
Event or Problem Description
The customer claims that some of the needles seem to be dull.

• Brand Name: MCKESSON
• Common Device Name: NEEDLE
• 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: 19349112
• Report Number: 3003560965-2024-00012
• Device Sequence Number: 7280723
• Product Code: FMI
• UDI-Device Identifier: 10612479206677
• UDI-Public: 10612479206677
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/20/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 16-N22105
• Device Lot Number: CKDC08-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 05/20/2024
• 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