MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. MONOJECT; MONOJECT HYPODERMIC SAFETY NEEDLE 25G*1"

Model Number	1182510
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.This report was initially submitted on 10/09/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
"the customer reported that a cma implemented the safety cap on the syringe by pushing the safety cap against the table.The cma then went to set the syringe on the table with their right hand and with their left hand grabbed a band-aid for the patient.The cma was stuck on the left-hand forefinger with the needle.It was stated that after the stick, the needle had unscrewed and the vaccine's pre-filled syringe fell to the floor and that is when the cma noticed that the needle had apparently bent separating from the safety cap and had malfunctioned allowing the needle to not be protected by the safety cap.Anecdotally, the customer reported that this event occurred on numerous instances.Specific incident information was not provided however they stated that when you close the safety cap, it actually just bends the needle.The needles do not fit properly into their syringes, and it is impossible to tighten them, and they often come unscrewed and fall off.The plastic safety cap also breaks off easily or gets bent when moving it out of the way to give an injection.Multiple staff members have had exposures due to needle pokes or near misses.They stated this is really unacceptable and a major safety concern for their staff who are frequently working with viremic hiv patients.Additionally, they stated that the safety doesn't always engage well, the needle is more likely to dislodge from the hub than other products, and the needles are more likely to bend.".
Additional Manufacturer Narrative
This report when initially submitted encountered an internal issue potentially related to database connectivity.This issue was identified while implementing capa-57 which was opened following an fda inspection.This supplemental mdr is being submitted to correct brand name provided in the initial mdr [3014312726-2024-00322].The previously reported was incorrect.The correct brand name is monoject.There is no evidence of quality issue associated with this complaint based on the archive sample analysis.

• Brand Name: MONOJECT
• Common Device Name: MONOJECT HYPODERMIC SAFETY NEEDLE 25G*1"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.; 311 s wacker dr, suite 4100; chicago IL 60606
• Manufacturer Contact: jarryd franklin ; no. 758, 5th binhai road; binhai industrial park; longwan ,wenzhou,, zhejiang province, IL ; CH
• MDR Report Key: 22035465
• Report Number: 3014312726-2024-00322
• Device Sequence Number: 8655767
• Product Code: FMI
• UDI-Device Identifier: 10884521544680
• UDI-Public: (01)10884521544680
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123684
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2026
• Device Model Number: 1182510
• Device Lot Number: 02105125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown