MAUDE Adverse Event Report: ICU MEDICAL, INC. JELCO VIAVALVE SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	328000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that after the iv was inserted and needle was retracted into the chamber, blood started leaking from the connection.In this incidence, blood started running down the patient's arm.There was a delay to treatment/therapy.
Additional Manufacturer Narrative
H2) device evaluation: d9 date returned to manufacturer: 7/9/2025.H3, h6: the device was returned for root cause analysis and the investigation findings concluded after visual inspection and functional testing.Received one used, locked out needle guard assembly without the catheter assembly and sheath and with blister top stock.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.Sample was visually evaluated for potential nonconformances.There was no evidence of blood pooling into the guard and nose components and no cannula o.D.Or nose i.D.Gaping noted that could potentially result in the reported leakage.Dried blood residue was identified in the flashback chamber and showed normal evidence of flash.Without the catheter assembly for the returned sample to evaluate for potential valve functionality issues, the complaint cannot be confirmed as the result of a manufacturing nonconformance, and root cause is unknown.In order to avoid blood pooling in the needle guard, the clinician needs to complete the insertion process and lock out the device without hesitation or pausing once the flash-vue window is beyond the valve.It is important to note, as the flash-vue window moves beyond the valve during this process, blood will continue to exit the window until the device is properly locked out.

• Brand Name: JELCO VIAVALVE SAFETY IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ICU MEDICAL, INC.; 201 west queen st; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22075803
• Report Number: 3012307300-2025-06073
• Device Sequence Number: 9337891
• Product Code: FOZ
• UDI-Device Identifier: 10351688081964
• UDI-Public: (01)10351688081964(17)270117(10)6087904
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: 328000
• Device Lot Number: 6087904
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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