MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. VIAVALVE SAFETY I.V. CATHETER; CATHETER INTRAVASCULAR, THERAPEUTIC, SHORT TERM

Device Problems Leak/Splash (1354); Unstable (1667); Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Product information, operator of device, initial reporter also sent report to fda, and pma/510(k) are unknown; no additional information was received.No lot number was provided; therefore, device history record (dhr) review could not be completed.No product was returned; therefore, no visual and functional testing could be performed, the failure mode reported could not be investigated and a root cause could not be determined.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

Event Description

It was reported that the device did not fit well with the holder, was hard to screw on straight, the back end boot would leak, was not as durable, not as sharp and was difficult to engage the safety.No patient injury was reported.

• Brand Name: VIAVALVE SAFETY I.V. CATHETER
• Type of Device: CATHETER INTRAVASCULAR, THERAPEUTIC, SHORT TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15397969
• MDR Text Key: 305795747
• Report Number: 3012307300-2022-18581
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1