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

Catalog Number	SB5021
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned; however, three photos of the device were provided for analysis.Functional and visual tests were performed.The complaint of a packaging issue can be confirmed by the images provided.The cause of the issue couldn't be determined.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this product lot.
Event or Problem Description
It was reported that the lot number on the packaging was misread due to a white line running through it.The actual lot number was 6064784 and was misread as 6061781.Approximately 50% of the needles had unclear lot numbers.There was no patient involvement.

• 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 ; 10 bowman drive; keene, NH 03431-0724 ; 2247062300
• MDR Report Key: 24532863
• Report Number: 1217052-2026-00012
• Device Sequence Number: 18409859
• Product Code: FMI
• UDI-Device Identifier: 20351688073928
• UDI-Public: (01)20351688073928(17)291017(10)6064784
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/06/2026

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: SB5021
• Device Lot Number: 6064784
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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