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

Catalog Number	4290
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 product received does not match the purchase order description.The order was for needle hypodermic safety 23g 25mm (1") blue pro c500-065/ptx and orange ones were received.Additionally, the needles received are packed in incorrect packaging with details of blue needles - 23g, but orange have a 25g.There was no patient involvement.
Additional Manufacturer Narrative
H3 and h6.Codes: updated.Device evaluation: received for investigation five presentation boxes containing packages of product part and lot number.The customer also provided a picture.Visual inspection of the hypodermic needles did not reveal any defects or anomalies.It was stated that the color of the needle protection device was incorrect and that the product they ordered was for the needle hypodermic safety 23g 25mm (1") blue pro c500-065/ptx.It is not clear what the customer identified as product code c500-065/ptx.Fifteen samples were removed from the packages (stratified through all presentation boxes) and the needle cannula length and gauge were verified.The length measurement was one inch, and the needle gauge was confirmed to be a 23g.Product # 4290 uses needle component (ne482) and needle-pro (mp836) which is a smiths medical legacy needle-pro luer lock device.The two components can be separated at the luer connections.All legacy needles have an orange needle-pro with varying-colored needle hubs to reflect the cannula length.Additionally, the tyvek package design created by smiths medical has a color code on the printed material which corresponds to the needle hub and the presentation box label has a stripe on it which correlates to the color on the needle hub.Based on these findings, this complaint could not be confirmed.No further action will be taken at this time.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 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: 21355630
• Report Number: 1217052-2025-00032
• Device Sequence Number: 9003111
• Product Code: FMI
• UDI-Device Identifier: 20351688046823
• UDI-Public: (01)20351688046823(17)270812(10)4317039
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: Other
• Device Catalogue Number: 4290
• Device Lot Number: 4317039
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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