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

Model Number	SYRSI193292
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the syringe volume markings had a "distorted view.".
Additional Manufacturer Narrative
It was reported that the syringe volume markings had a "distorted view." additionally, the reporting facility indicated that the safety mechanism of the needle was not locking.No serious injury or adverse impact to a patient or a user was originally reported.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.No photo or sample were provided for evaluation.The reported problem/issue was unable to be reproduced or confirmed and a root cause was unable to be determined.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: 19016241
• Report Number: 1417592-2024-00324
• Device Sequence Number: 12804961
• Product Code: FMF
• UDI-Device Identifier: 30888277657308
• UDI-Public: 30888277657308
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/01/2024

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: 89718060001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/01/2024
• 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