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

Lot Number	20221030
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 and simulated usage procedure, no similar problem was found.Preliminary judgement was the usage for vial penetration, video clip or more information is needed for furhter investigation for a thorough investigation.On 2024.02.26 5 pieces of 30g×1/2"(0.3mm×13mm) needles were sampled from retained sample lot no.20221030 for simulated patency of lumen test under 20kpa water pressure, the result was qualified.After reviewing of product records, no abnormities were found, and based on the customer feedback, preliminary judgement was the usage for vial penetration when usually in clinical setting operator would use a hypodermic needle for vial puncture instead of a dispensing needle, other factors including needle tube blockage from silicone oil or foreign matter could be exluded as in-process controls were in place, video clip or more information is needed for furhter investigation for a thorough investigation.Relevant internal report 20240373 and other documents could be provided upon request.
Event or Problem Description
Customer advised that one box of syringes are clogging up.No adverse events caused.Syringes just wont dispense the fluids.

• Brand Name: HENRY SCHEIN BRAND
• 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 Contact: suhua li ; no. 758, 5th binhai road; wenzhou, zhejiang 32502-5 ; CH 325025
• MDR Report Key: 19266041
• Report Number: 3003560965-2024-00010
• Device Sequence Number: 17891803
• Product Code: FMI
• UDI-Device Identifier: 00304040003084
• UDI-Public: 00304040003084
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Device Lot Number: 20221030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2024
• 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: 30G×1/2' NEEDLE LOT NO. 20221030
• Patient Sex: Unknown