MAUDE Adverse Event Report: ICU MEDICAL, INC., SOUTHINGTON CT JELCO VIAVALVE SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Catalog Number	326010
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle did not retract correctly.The blood also entered the top of device where it should not be, and blood was leaking at the connection chamber and hub.The event occurred multiple times while in use with a patient, and there were unknown signs or symptoms experienced.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).H3, 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.
Additional Manufacturer Narrative
H6: codes were updated.One device was returned for investigation.The reported that issue was locked out viavalve needle-guard assembly with blister top stock and without catheter assembly & sheath.The probable cause for the reported complaint of catheter leakage and safety mechanism malfunction could not be determined.The sample displayed evidence of damaged porous barrier in the housing flash chamber area with visible blood leakage past barrier component.The damage to the component was highly probable to have occurred due to a fault during the assembly process.Based on analysis, the complaint is confirmed as a manufacturing error.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: JELCO VIAVALVE SAFETY IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): ICU MEDICAL, INC., SOUTHINGTON CT; 201 west queen street; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22441331
• Report Number: 3012307300-2025-08048
• Device Sequence Number: 15436830
• Product Code: FOZ
• UDI-Device Identifier: 15019517078398
• UDI-Public: (01)15019517078398(17)270308(10)6103154
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 326010
• Device Lot Number: 6103154
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown