MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. MONOJECT HYPODERMIC SAFETY NEEDLE 25G*5/8"; HYPODERMIC NEEDLE

Model Number	1182558
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
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 hypodermic safety needle 25g x 5/8", ref 1182558, lot: 02102036 with no anomalies found on batch documentation.No samples were received by the customer for evaluation.Archive sample evaluation: 50pcs of archive samples have been visually checked with no anomalies found on the needle hub.5pcs of archive samples have been checked in accordance with iso 80369-20:2015, annex e.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.
Event or Problem Description
The customer reported that the side of the orange needle had a slight split in the plastic resulting in treatment being leaked onto the nurse administering it.No harm or injury was reported.

• 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 ; 4049732200
• MDR Report Key: 14775308
• Report Number: 3014312726-2022-00004
• Device Sequence Number: 4999802
• Product Code: FMI
• UDI-Device Identifier: 10884521544710
• UDI-Public: 10884521544710
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101359
• 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): 04/13/2022

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: 04/25/2026
• Device Model Number: 1182558
• Device Catalogue Number: 1182558
• Device Lot Number: 02102036
• 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: 04/13/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2021
• 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