MAUDE Adverse Event Report: ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. HENRY SCHEIN BRAND; NEEDLE DISPOSABLE

Lot Number	20230405
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer advised that the needle is piercing the rubber stopped in a way that is causing rubber fragments to fall into the vials.
Additional Manufacturer Narrative
Upon receipt of customer complaint, personnel from quality, production and other relevant departments were involved in the investigation including retained sample inspection, production process review, no similar problem was found, however hypodermic needle is more likely to coring compared to a dispensing needle during vial puncture.On 2024.03.29 25 pieces of 18g*1 1/2" needles were sampled from the retained sample lot no.2023.0405 for visual inspection under 10 times magnifier, no needle point defect was found, another 25 pieces of 18g*1 1/2" dispensing needles sampled from c202403671 were used for coring test to perform vial puncture tests, the test results were all qualified except that the hypodermic needle is more likely to have fragmentation.Hypodermic needles manufactured by us are used for hypodermic injection and avoid damage to the vein during puncture, when using the product for vial puncture then the coring process may occur and it is recommended for the customer to remind the end-user that dispensing needle should be used during medicinal fluid preparation instead of using hypodermic needles.More information is needed for further investigation for a thorough investigation, relevant internal report (b)(4) and other documents could be provided upon request.

• Brand Name: HENRY SCHEIN BRAND
• Common Device Name: NEEDLE DISPOSABLE
• Manufacturer (Section D): 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: 19266043
• Report Number: 3003560965-2024-00009
• Device Sequence Number: 6997267
• Product Code: FMI
• UDI-Device Identifier: 00304040002834
• UDI-Public: 00304040002834
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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 Lot Number: 20230405
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 05/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 18G×1 1/2" NEEDLE DISPOSABLE LOT NO. 20230405
• Patient Sex: Unknown