MAUDE Adverse Event Report: CVC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dehydration (1807); Sepsis (2067); Vomiting (2144)

Event Date 02/07/2017

Event Type  Injury  

Event Description

Cvc placement by trauma services; cxr revealed guidewire was retained within the ivc; patient taken to vir with attempt to aspirate-failed; entire cvc pulled and guidewire remained.Guidewire removed in vir patient presented with vomiting, dehydration; sirs criteria met; sepsis alert; attempted placement of cvc failed.Transport patient to unit; trauma surgery notified for cvc placement.Cvl placed.No further complications.Pending explant date (b)(6) 2017.

• Brand Name: CVC
• Type of Device: CVC
• MDR Report Key: 6321981
• MDR Text Key: 67263310
• Report Number: MW5067826
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR