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

Model Number	4281
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: 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 information becomes available.
Event or Problem Description
It was reported that the needle detached easily when drawing medicine, and then medicine leaked out from the needle hub.There was no patient involvement.
Additional Manufacturer Narrative
The actual device(s) used at the time of the complaint, was not returned for investigation.Visual inspection did not reveal any defects or anomalies.All samples were unopened and within the original packages the needles were assembled to the needle-pro devices.To determine if the needles became detached from the needle-pro devices or if the needle-pro detached from a syringe, the samples were assembled by firmly seating the needle to the needle-pro and the needle-pro to a test syringe, using a push and a slight twist.Using a medication vial (0.9% sodium chloride for injection) to simulate actual use, of drawing medication from a vial and/or injecting the patient, the needle cannula was inserted within the septum site of the vial.Medication was drawn up and then expelled back into the vial.All results were acceptable with the samples remained assembled and no detachment observed.To test for possible leakage and/or detachment between mating luers, the samples were assembled to a fluid filled stock syringe.The assemblies were tested according to combo leak test (qtm\022-00-00).Results: the returned samples functioned as intended.No leakage was observed between the mating luers and no detachment of the needle from the needle-pro devices was observed.Refer to attached data sheets for details.The issue observed by the customer could not be reproduced with the returned samples.Therefore, the complaint could not be confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: JELCO CATHETER
• 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: 21995960
• Report Number: 3012307300-2025-05463
• Device Sequence Number: 11834156
• Product Code: FMI
• UDI-Device Identifier: 20351688046748
• UDI-Public: (01)20351688046748(17)291023(10)6068016
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 09/15/2025

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 Model Number: 4281
• Device Catalogue Number: 4281
• Device Lot Number: 6068016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown