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

Catalog Number	4290
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: three sealed packages were received for investigation.A visual inspection of the hypodermic needles did not reveal any defects or anomalies.The samples were removed from the packages and the needle cannula length and gauge were verified.The bill of material for the supplied needle ne482 was reviewed and found to be compliant with iso6009.The customer also provided three pictures.One of the photos had representations of patented smiths medical needle-pro edge hypodermic needles.These products have a needle-pro affixed to the cannula.Product # 4290 uses needle component (ne482) and needle-pro (mp836) which is a smiths medical legacy needle-pro luer lock device and the two components can be separated at the luer connections.This finished good does not contain the smiths medical trademarked needle-pro assembly.All legacy needles have an orange needle-pro with varying-colored needle hubs to reflect the cannula length.Sm edge needle-pro needle products have different needle protection hues depending on the needle gauge.The assembly machines used to manufacture these two types of hypodermic needles are different tiromat designs.One is specific to the manufacture of edge products.Additionally, the tyvek package design created by smiths medical has a color code on the printed material which corresponds to the needle gauge.Based on these findings, this complaint could not be confirmed.No further action will be taken at this time.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.Dhr review found no discrepancies or anomalies relevant to the complaint.
Event or Problem Description
It was reported that there was an issue identified with the jelco needle-pro syringes 23g gauges.They have orange colored needle protection devices, which is associated with 25g needles.The photo of the needles in their packaging makes it difficult to distinguish their gauges.Upon closer inspection, after removing the needles from their packaging and covers, they found that the needles are blue.The nhs supply chain image shows that the needle protection should match the needle color.This discrepancy could lead to incidents with patients if the wrong needle is used.There was no human harm reported.

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO 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: 21118729
• Report Number: 1217052-2025-00010
• Device Sequence Number: 7436440
• Product Code: FMI
• UDI-Device Identifier: 20351688046823
• UDI-Public: (01)20351688046823(17)270816(10)4320595
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

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: 4290
• Device Lot Number: 4320595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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: Unknown