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

Lot Number	20210110
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
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 , no similar problem was found.On 2024.03.21 10 pieces of 1ml 27g×1/2" syringes were sampled from retained sample lot no.20210110 for simulated clinical operation, no leakage or abnormality was found after conical fitting test.After review of production records, no abnormality was found.It could not be determined the leakage place, more information is needed for furhter investigation for a thorough investigation.Relevant internal report 20240342 and other documents could be provided upon request.
Event or Problem Description
The customer advised that the item is leaking.

• Brand Name: HENRY SCHEIN BRAND
• Common Device Name: SINGLE USE SYRINGES WITH 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: 19266034
• Report Number: 3003560965-2024-00008
• Device Sequence Number: 20582245
• Product Code: FMF
• UDI-Device Identifier: 10304040134181
• UDI-Public: 10304040134181
• 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: 20210110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2024
• 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: 1ML 27G×1/2" SINGLE USE SYRINGES WITH NEEDLE
• Patient Sex: Unknown