MAUDE Adverse Event Report: ICU MEDICAL, INC. JELCO EDGE 3ML NEEDLE W/ SYRINGE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	432215
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 1217052-2025-00051-00.The date of that submission was 02-mar-2025.H6: codes were updated.One device was returned for investigation.It was reported that syringes have been leaking out of the plunger.Results: leakage past the plunger was observed with 27 of the provided products.Based on the results of this investigation this complaint was confirmed.Inadequate manufacturing from the supplier is the root cause of this issue.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Event or Problem Description
It was reported that the device was not able to pull-out medications completely while in use on the patient.The medication seemed to leak out on the back of the syringe.There were no patient harm or adverse effects reported as a result of the event.

• Brand Name: JELCO EDGE 3ML NEEDLE W/ SYRINGE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): ICU MEDICAL, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23522333
• Report Number: 3012307300-2025-12310
• Device Sequence Number: 9770061
• Product Code: FMI
• UDI-Device Identifier: 00351688071029
• UDI-Public: (01)00351688071029(17)260416(10)4141025
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K071785
• 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
• Report Date (Section B): 11/11/2025

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: Health Professional
• Device Expiration Date: 04/16/2026
• Device Catalogue Number: 432215
• Device Lot Number: 4141025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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