MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO 3ML NEEDLE-PRO W/ SYRINGE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	4236
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 reportable information becomes available.
Event or Problem Description
It was reported that the syringe leaked while drawing up medication.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
No product sample was provided for evaluation.As a result, the investigation could not confirm whether a quality-related issue contributed to the reported problem.The complaint could not be verified.Therefore, no further action will be taken at this time.A device history review was performed and no discrepancies or anomalies relevant to the complaint were identified.

• Brand Name: JELCO 3ML NEEDLE-PRO W/ SYRINGE
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20598869
• Report Number: 1217052-2024-00168
• Device Sequence Number: 8787892
• Product Code: FMI
• UDI-Device Identifier: 20351688048827
• UDI-Public: (01)20351688048827(17)260126(10)4107237
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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 Expiration Date: 01/26/2026
• Device Catalogue Number: 4236
• Device Lot Number: 4107237
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2021
• 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: Unknown