MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE, LUER LOCK, STERILE, 3ML

Model Number	SYR103010
Medical Device Problem Codes	Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the syringe is leaking and that needles are "falling out.".
Additional Manufacturer Narrative
It was reported that the syringe is leaking during vaccine administration and that the attached needles are "falling out." 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 sample was returned for evaluation and a root cause was unable to be determined.Due to the reported problem/issue, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: SYRINGE, LUER LOCK, STERILE, 3ML
• 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: 18743413
• Report Number: 1417592-2024-00077
• Device Sequence Number: 6380297
• Product Code: FMF
• UDI-Device Identifier: 40080196310167
• UDI-Public: 40080196310167
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/20/2024

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: SYR103010
• Device Lot Number: 201204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 02/20/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown