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

Catalog Number	326010
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 while starting a peripheral iv, the writer noticed blood leaking from the hub after the needle was secured in the chamber.There was patient involvement, and no harm/adverse event reported.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: no product sample 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.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.
Additional Manufacturer Narrative
H6: codes were updated.One device was returned for investigation.The reported complaint via valve needle guard assembly without catheter assembly and sheath, and with blister top stock for analysis.Sample was visually evaluated for potential nonconformances and met product specification requirements for the reported complaint.Without the catheter assembly for the returned sample to evaluate for potential valve functionality issues, the probable cause for the reported complaint of leakage could not be determined and there was no evidence of foreign matter contamination in the received sample.In-process and at post sterile, product is evaluated for seal leakage and visually inspected by operators using statistically valid sampling plans at defined intervals.If any nonconformances are found in process, the product is isolated, non-conformed and immediate corrective action is taken.Inspections and tests are conducted by trained operators using statistically valid sampling plans at defined intervals.Sampling plans are based on random sampling selection and are designed to provide a high level of assurance that the true fraction defective is less than or equal to the established aql level for each quality characteristic.Complaint information will continue to be monitored.Icu medical regularly reviews and analyzes post-market data for new information or adverse trends, implementing corrections, taking corrective and preventative actions accordingly.This complaint was incorrectly filed under this registration number, please reference mrn 3012307300-2025-12473-00 and 3012307300-2025-12474-00 for details pertinent to this event.

• Brand Name: JELCO VIAVALVE¿ SAFETY IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20724849
• Report Number: 1219611-2024-00055
• Device Sequence Number: 3756822
• Product Code: FOZ
• UDI-Device Identifier: 15019517078398
• UDI-Public: (01)15019517078398(17)260823(10)6037370
• 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,Followup
• Report Date (Section B): 11/14/2025

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: 08/23/2026
• Device Catalogue Number: 326010
• Device Lot Number: 6037370
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 01/07/2025; 10/28/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/30/2025; 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown