MAUDE Adverse Event Report: ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD MEDLINE INDUSTRIES,LP; HYPDERMIC NEEDLE

Model Number	30G¡Á0.5''
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the needle broke inside the patient's body during injection.
Additional Manufacturer Narrative
1.Production process review: the production records of this batch were examined, showing no abnormalities during the manufacturing process.The investigation was conducted from the following aspects: personnel: all production operators were properly trained and certified before assignment.As the product is assembled using automated equipment with no processing errors, this factor can be excluded.Equipment: production equipment undergoes daily inspections and regular maintenance.First-article inspections are conducted at each shift changeover with no anomalies detected, ruling out this factor.Materials: no changes were made to raw materials.Incoming needle tubes undergo rigidity and toughness testing prior to use, and finished products are similarly tested before release, excluding this factor.Method: no modifications were made to the production process.However, the needle tubes of this specification (30g) are particularly slender and prone to bending under force.Excessive bending beyond the tube's tolerance limit (normal range: 25¡ã) during clinical procedures may lead to fracture.Environment: the product is assembled in a controlled cleanroom environment.As the needle fracture occurred during usage, production environmental factors can be excluded.Batch sample testing: ten retained samples from batch 220411 (specification: 30g¡á0.5" hypodermic needles) were tested as follows: visual inspection: all samples showed complete bonding between needle tubes and hubs with sufficient adhesive fill.No physical defects were observed on any needle tubes.Performance testing: all 10 samples passed rigidity and toughness testing per iso 7864:2016 requirements.Detailed results are documented in the retained sample test report.Root cause analysis: based on the investigation, the probable cause is the inherent slenderness of this needle specification (30g).During clinical use, either improper handling technique or excessive patient movement may have caused the needle tube to bend beyond its mechanical tolerance (25¡ã maximum bend angle), resulting in fracture.

• Brand Name: MEDLINE INDUSTRIES,LP
• Common Device Name: HYPDERMIC 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: 22871940
• Report Number: 3003560965-2025-00017
• Device Sequence Number: 5687740
• Product Code: FMI
• UDI-Device Identifier: 30080196305630
• UDI-Public: 30080196305630
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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: 30G¡Á0.5''
• Device Catalogue Number: SYR100302
• Device Lot Number: 220411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/22/2025
• 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
• Patient Sex: Unknown