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

Catalog Number	402558
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.Device has not been returned to manufacturer.
Event or Problem Description
It was reported that during an intended flu vaccine procedure, the flu vaccine leaked out.The customer stated that they felt this was due to the hub not being tight.Another vaccine was obtained and given to the patient with no patient harm resulting from the event.The customer states that leaking from the pre-filled syringes has been an ongoing issue.
Additional Manufacturer Narrative
No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO EDGE
• 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: 20689372
• Report Number: 3012307300-2024-13310
• Device Sequence Number: 8529176
• Product Code: FMI
• UDI-Device Identifier: 00351688066551
• UDI-Public: (01)00351688066551(17)271018(10)4339841
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 402558
• Device Lot Number: 4339841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2022
• 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 Age: 3 YR
• Patient Sex: Male