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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the iv catheter was not flowing.There was no patient involvement and no patient harm/adverse event reported.
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.
Additional Manufacturer Narrative
No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• 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 lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19601052
• Report Number: 1219611-2024-00017
• Device Sequence Number: 15484214
• Product Code: FOZ
• UDI-Device Identifier: 15019517078398
• UDI-Public: (01)15019517078398(17)260208(10)4464222
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: 02/08/2026
• Device Catalogue Number: 326010
• Device Lot Number: 4464222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2024
• 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