MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE, LUER LOCK, STERILE, 20ML

Model Number	SYR120010H
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the plunger of the syringe was difficult to push.The problem/issue was reportedly identified while administering propofol medication through an iv.No serious injury or adverse patient impact was reported at the time of the original report.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 problems/issues.Samples were returned for evaluation and visual inspection observed no manufacturing defects of the plunger seal, plunger, and barrel.Simulated injection was performed with no additional force needed to flush the syringe.Difficulty with pushing the plungers was identified, however, when the tubing being flushed was kinked or obstructed.The reported problem/issue was not confirmed during normal use.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.
Event or Problem Description
It was reported that the plunger of the syringe was difficult to push.

• Common Device Name: SYRINGE, LUER LOCK, STERILE, 20ML
• 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: 18921843
• Report Number: 1417592-2024-00158
• Device Sequence Number: 18077250
• Product Code: FMF
• UDI-Device Identifier: 10080196310227
• UDI-Public: 10080196310227
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/17/2024

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: SYR120010H
• Device Lot Number: 190320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 03/18/2024
• 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