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

Catalog Number	402510
Medical Device Problem Code	Fluid/Blood Leak (1250)
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
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 reportable information becomes available.
Event or Problem Description
It was reported that when the operator of the device pushed on the plunger, the liquid came out at the side of the syringe and onto the patient's arm and shirt.
Additional Manufacturer Narrative
D9 - date returned to mfg: 07-oct-2025.H3: one used product and pictures were received for analysis.The sample was viewed under magnification, and a crack was noted on the hub of the needle-pro (mp964).Prior to testing the hinges of the pro was severed and removed to allow the cannula to be exposed.It then was assembled to a fluid filled, 3ml, luer-lock syringe from stock according to ifu (as10011059-002, sections 6.2 & 6.3), by firmly seating the needle-pro to the syringe and needle to the needle-pro, using a push and a clockwise twist.The assemblies were tested and the sample leaked.Review of the maintenance logs for the assembly machines, did not identify any issues that could potentially be associated with a crack on the side of the edge needle-pro hub.Per an engineering area technician, the machine assembly process is the same for the different sizes of edge needle-pro components and does not include any factors or conditions specific to the 25g size component.Complaint information will continue to be monitored for any new information or adverse trends, and further actions will be taken accordingly.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO EDGE NEEDLES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21965070
• Report Number: 3012307300-2025-05230
• Device Sequence Number: 8123002
• Product Code: FMI
• UDI-Device Identifier: 00351688066544
• UDI-Public: (01)00351688066544(17)270927(10)4333134
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K041399
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: 402510
• Device Lot Number: 4333134
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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