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

Model Number	SYR105010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "the wings of the syringe snapped" during a central line insertion procedure.When the broken syringe was identified, it was discarded and a new syringe was obtained and used for the procedure without further reported incident.No death, serious injury, medical intervention, follow-up care, or other adverse patient/health impact has been reported to the manufacturer.Although the original syringe sample was not available for return, testing was performed using reserved stock of syringes from the reported lot of product.Visual inspection identified no manufacturing defects that would prevent the samples from working properly.Blunt tip needles were then attached to samples with various fluid volumes drawn in and expelled from the syringes at various forces.No issues were identified during functional testing and no samples were identified to have leaked or cracked.The reported problem/issue could not be confirmed through testing and definitive root cause could not be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that "the wings of the syringe snapped.".

• Common Device Name: SYRINGE, LUER LOCK, STERILE, 5ML
• 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: 18659091
• Report Number: 1417592-2024-00056
• Device Sequence Number: 12815168
• Product Code: FMF
• UDI-Device Identifier: 10080196310173
• UDI-Public: 10080196310173
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/07/2024

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
• Operator of Device: Health Professional
• Device Model Number: SYR105010
• Device Lot Number: 220905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 02/07/2024
• 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