MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. MONOJECT 1ML SYRINGE W/HYPODERMIC SAFETY NEEDLE 27G*1/2; HYPODERMIC NEEDLE

Model Number	11812705
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: when the physician used a tb needle/syringe to inject a local anesthetic on an infant, it was difficult to draw up the medication.There were multiple attempts made to fill the syringe and draw up the medication.When removing air from the syringe, the needle portion fell off the syringe.The intended procedure: was to administer local anesthetic.
Additional Manufacturer Narrative
The complaint device was not to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.The production site checked the batch record of impacted monoject 1ml syringe w/hypodermic safety needle 27g x ½", ref 11812705, lot 01107028 with no anomalies found on batch documentation.No samples were received by the customer for evaluation.Archive sample evaluation: visual check: 50pcs have been visually checked with no loosen needle or detached needle found.Simulation test: 10pcs have been tested by withdrawing and ejecting water from the syringe and finally activating the safety mechanism.No difficulty in the withdrawal of water into the syringe, no detached needles were found.Resistance to separation from axial load test: 5pcs have been checked in accordance with iso 80369-20:2015, annex f.All samples tested passed the test.Resistance to separation from unscrewing test: 5pcs have been checked in accordance with iso 80369-20:2015, annex g.All samples tested passed the test.Resistance to overriding test: 5pcs have been checked in accordance with iso 80369-20:2015, annex h.All samples tested passed the test.Risk statement: the overall risk assessment, given the severity assessment of s3-moderate injury and a probability assessment of p2-low, the final risk priority number is 6.Risk level is in green area/low risk according to our risk management procedure.

• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 315 shawnee north drive; suite 100; suwanee GA 30024
• Manufacturer (Section G): SOL-MILLENNIUM MEDICAL INC.; 315 shawnee north drive; suite 100; suwanee GA 30024
• Manufacturer Contact: shari wiley ; 315 shawnee north drive; suite 100; suwanee, GA 30024
• MDR Report Key: 14778103
• Report Number: 3014312726-2022-00005
• Device Sequence Number: 14720977
• Product Code: FMI
• UDI-Device Identifier: 10884521544796
• UDI-Public: 10884521544796
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K123684
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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 Expiration Date: 07/26/2026
• Device Model Number: 11812705
• Device Catalogue Number: 11812705
• Device Lot Number: 01107028
• 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: 05/11/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• 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