MAUDE Adverse Event Report: SMITHS MEDICAL JELCO PROTECT IV PLUS-W SAFETY IV CATHETER; INTRAVENOUS CATHETER

Lot Number 3627163

Device Problems Tip breakage (1638); Detachment of Device or Device Component (2907)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 08/06/2018

Event Type  Injury  

Event Description

As the nurse attempted to remove the pt's iv/vascular access device, she noted that the catheter was not intact.Length was short when compared to an unused catheter.The physician ordered a consult with a vascular surgeon.On (b)(6) 2018, the pt went to the operating room for removal of the tip.The pt tolerated the procedure well and was taken to the recovery room in stable condition.

• Brand Name: PROTECT IV PLUS-W SAFETY IV CATHETER
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): SMITHS MEDICAL JELCO; 5200 upper metro place s. ; dublin OH 43017
• MDR Report Key: 7957736
• MDR Text Key: 123510882
• Report Number: 7957736
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3627163
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2018
• Distributor Facility Aware Date: 08/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2018
• 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: 80 YR