MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M 1ML LUER LOCK SYRINGE W/O NEEDLE (PP) (LOW DEAD SPACE)

Model Number	P180001PP
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that they got a whole box of sol-m 1ml luer lock syringes without needles from the pharmacy as i must give myself an injection every week.My usual pharmacy carries a different brand, but i couldn't get them in bulk from there, so this was my first time using sol-m syringes.(previously i had used bd syringes).I'm injecting testosterone enanthate (in sesame oil) and my only guess is that it's too thick to inject smoothly.I must press down really hard to get the plunger to move at all and when it does it's jerky.I've tried warming the filled syringe with my hands and a little with my space heater, but it hasn't helped.
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the return sample and archive sample analysis.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 1ML LUER LOCK SYRINGE W/O NEEDLE (PP) (LOW DEAD SPACE)
• 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. 501, shunfeng rd.,; linping district; 311106 hangzhou, zhejiang, ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22392117
• Report Number: 3014312726-2025-00161
• Device Sequence Number: 21099824
• Product Code: FMF
• UDI-Device Identifier: 00818392018165
• UDI-Public: (01)00818392018165(10)04409034
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K242291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: P180001PP
• Device Lot Number: 04409034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• 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