MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-SYRINGE,LUER LOCK,STERILE,5ML,PUMPC

Catalog Number	SYR105010PC
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a "contaminant" was noted to be inside the syringe after drawing up medication.The customer was unable to determine if the "contaminant" came from the medication or the syringe.The customer reported the syringe was replaced and a new medication vial was used to complete the administration.No additional details are available related to the customer reported issue.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.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 for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a "contaminant" was noted to be inside the syringe after drawing up medication.
Additional Manufacturer Narrative
Incorrect product information was documented on original medwatch 3500a form 1417592-2025-00052.The following information has been corrected: correction to d2a: common device name correction to d2b: device product code correction to d4: catalog number, lot number, and primary unique device identifier (udi) number.

• Common Device Name: DBD-SYRINGE,LUER LOCK,STERILE,5ML,PUMPC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21293517
• Report Number: 1417592-2025-00052
• Device Sequence Number: 15784789
• Product Code: FMF
• UDI-Device Identifier: 30193489181672
• UDI-Public: 30193489181672
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SYR105010PC
• Device Lot Number: 89723020001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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