MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. SOL-CARE LUER LOCK SYRINGE

Model Number	120007IM
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
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 information is identified, a supplemental medwatch will be filed.No samples were received by the customer for evauation.
Event or Problem Description
The customer reports icu rns were trying to transfer blood from syringe to specimen tube.The needle pulled inside the syringe to specimen tube.The needle pulled inside the syringe and blood splashed everywhere.

• Brand Name: SOL-CARE LUER LOCK SYRINGE
• Common Device Name: SYRINGE
• 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 ; 3347407814
• MDR Report Key: 15655595
• Report Number: 3014312726-2022-00008
• Device Sequence Number: 12377746
• Product Code: MEG
• UDI-Device Identifier: 00818392014853
• UDI-Public: 00818392014853
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K092430
• 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): 09/01/2022

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: 02/28/2026
• Device Model Number: 120007IM
• Device Lot Number: 04102046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2021
• 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