MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M 20ML LUER LOCK SYRINGE W/O NEEDLE

Model Number	P180020BS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation in-progress.No samples are available of the suspect device.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Customer reported following two complaints, customer description: (b)(4).The problem was that one of the 20 ml syringes was broken at the tip.We couldn't find the tip anywhere, but there is concern about whether there might be a loose piece to watch out for during the surgery.No harm reported.Customer description: (b)(4).A 20 ml syringe tip that snapped off in hub of drug eluting stent when prepping ( de-airing) the stent for delivery.This left the stent unusable, so a new syringe and stent were opened.These were then used to complete stenting.This is a massive expense to the customer.No harm reported.
Additional Manufacturer Narrative
Our evaluation of the risk, which follows guidance from iso 14971, indicates that the overall risk for the reported failure is low.This evaluation is based on our track and trend analysis and risk management files which are evaluated and updated constantly based on post market surveillance.All the archive samples tested were within the product specification requirements.Received sample analysis confirms the morphological features observed that includes torn and twisted surfaces, irregular sharp edges, and internal deformation lines, clearly indicates that the damage was caused by excessive torsional force applied during use.Therefore, the failure is attributed to mechanical overload resulting from improper handling or application of rotational force beyond the design limits of the component.As part of our continued commitment to our customers, sol millennium will continue to monitor the complaints trend for the reported failure mode and take any corrective action based on our procedures, if a significant pattern emerges.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 20ML LUER LOCK SYRINGE W/O NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr.,; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG LONGDE PHARMACEUTICAL CO., LTD.; no.510 shunfeng road; linping district hangzhou; zhejiang, 31110 6; CH 311106
• Manufacturer Contact: intheran annadurai ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 22382249
• Report Number: 3014312726-2025-00151
• Device Sequence Number: 8411289
• Product Code: FMF
• UDI-Device Identifier: 00810018095185
• UDI-Public: (01)00810018095185(10)04405050
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K222744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: P180020BS
• Device Lot Number: 04405050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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