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

Catalog Number	4290
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle disconnected from safety shield and partial amount of medicine did not get injected into patient.This resulted the needle being stuck in the skin while the syringe was detached from the safety shield.The nurse was able to pull the needle out.The patient required no medical intervention as a result of the event.
Additional Manufacturer Narrative
No product sample has been provided, and the investigation could not confirm whether a quality related issue has resulted in the customer reported problem.The reported problem could not be verified and/or confirmed with confidence; therefore, no further action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and take further actions accordingly.

• Brand Name: JELCO HYPO NEDL-PRO
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21473818
• Report Number: 1217052-2025-00050
• Device Sequence Number: 12971840
• Product Code: FMI
• UDI-Device Identifier: 20351688046823
• UDI-Public: (01)20351688046823(17)280215(10)4378190
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

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: 4290
• Device Lot Number: 4378190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2023
• 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: 30 MO
• Patient Sex: Unknown
• Patient Weight: 19 KG
• Patient Ethnicity: Hispanic
• Patient Race: White