MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYR W/NDLE,SAFETY,25GX1, 3ML

Catalog Number	SSN103255Z
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility the "needle is falling off/out of the syringe when trying to cap the needle after use".Per the facility the syringe/needle is being "capped" by "engaging the safety lever".Per the facility "the needle was confirmed to be securely attached to the syringe".Per the facility there was no impact to the patient and no serious injury or medical intervention required.A sample has been requested for evaluation.No additional information is available at this time.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
According to the facility the "needle is falling off/out of the syringe when trying to cap the needle after use".
Additional Manufacturer Narrative
Supplemental medwatch filed to add product expiration date.

• Common Device Name: SYR W/NDLE,SAFETY,25GX1, 3ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20682840
• Report Number: 1417592-2024-00958
• Device Sequence Number: 17950542
• Product Code: FMI
• UDI-Device Identifier: 20193489037927
• UDI-Public: 20193489037927
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/14/2024

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 Catalogue Number: SSN103255Z
• Device Lot Number: 8972202002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 11/14/2024
• 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
• Patient Sex: Unknown