MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYR W/NDLE,SAFETY,INSLN,0.5ML,29GX0.5"

Model Number	SYRSI193292
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that medication drawn into the syringe would return to the vial and that it leaked.
Additional Manufacturer Narrative
It was reported that after drawing up insulin into the syringe, "the vial would suck the medicine back down into the vial." the reporting facility also indicated that leakage of insulin was noted whenever filled syringes were transported using the facility's pressurized tube vacuum system.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.Five (5) boxes of unused product was returned for evaluation and seventy-five (75) samples were randomly selected for evaluation.Visual inspection revealed no manufacturing or other defects that would prevent he samples from working as intended.Simulated drawing was performed using all samples with a training vial filled with water.No vacuum-related issues were experienced no water was released back into the vial when the plunger was released after filling the syringes.The fluid remained within the syringe until force was applied to the plunger to remove the fluid.All samples worked as intended.The reported problem/issue of fluid returning to the vial may be caused by not injecting air into the vial prior to drawing up medication.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: SYR W/NDLE,SAFETY,INSLN,0.5ML,29GX0.5"
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18865318
• Report Number: 1417592-2024-00207
• Device Sequence Number: 3313768
• Product Code: FMF
• UDI-Device Identifier: 30888277657308
• UDI-Public: 30888277657308
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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
• Device Model Number: SYRSI193292
• Device Lot Number: 89722090001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown