MAUDE Adverse Event Report: MEDEFIL, INC. HEPARIN LOCK FLUSH SYRINGE 10 UNITS/ML; HEPARIN, VASCULAR ACCESS FLUSH

Model Number	3ML IN 12ML SYRINGE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Heparin lock flush labels are put on crooked, therefore, when plunger brought to 1ml line syringe actually has 1.4ml med.

• Brand Name: HEPARIN LOCK FLUSH SYRINGE 10 UNITS/ML
• Common Device Name: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): MEDEFIL, INC.; 250 windy point dr; glendale heights IL 60139
• MDR Report Key: 17396537
• Report Number: 17396537
• Device Sequence Number: 7556614
• Product Code: NZW
• UDI-Device Identifier: 30364253222338
• UDI-Public: (01)30364253222338
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/09/2023
• Report Date (Section F): 05/09/2023

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: 3ML IN 12ML SYRINGE
• Device Catalogue Number: MIH-2233
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 05/09/2023