MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO HYPODERMIC NEEDLE-PRO EDGE NEEDLES; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	402510
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medwatch 4326210 that the nurse was giving flu vaccine high dose and vaccine leaked out of syringe.There was patient involvement and unknown adverse event.
Additional Manufacturer Narrative
H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H6: codes were updated.No device was received for investigation.Therefore, the reported complaint is unable to be confirmed.If the device is received, the investigation will be re-opened for further evaluations.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO EDGE NEEDLES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21124846
• Report Number: 1217052-2025-00011
• Device Sequence Number: 8682772
• Product Code: FMI
• UDI-Device Identifier: 00351688066544
• UDI-Public: (01)00351688066544(17)270830(10)4326210
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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 Catalogue Number: 402510
• Device Lot Number: 4326210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female