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

Lot Number 3756739

Device Problems Crack (1135); Fluid/Blood Leak (1250); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2019

Event Type  malfunction  

Event Description

As rn placed piv in right antecubital, the catheter bent and developed a crack that resulted in a leak making it ineffective.Rn assured catheter was completely removed.

• Brand Name: VIAVALVE SAFETY
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9271414
• MDR Text Key: 164837928
• Report Number: 9271414
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3756739
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1