MAUDE Adverse Event Report: SMITHS MEDICAL PROTECTIV PLUS SAFETY IV CATHETER ANGIOCATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 3060

Device Problems Material Perforation (2205); Physical Resistance/Sticking (4012)

Patient Problem Injury (2348)

Event Date 08/22/2018

Event Type  malfunction  

Event Description

While inserting smiths medical 22g x 1" protective plus safety iv catheter into vein (left forearm), i saw the blood flash, but while trying to advance the angio. I immediately felt resistance. I removed the catheter / needle, and saw that the needle had perforated the angio catheter. A pressure dressing was applied to the forearm. The angio catheter was noted to be intact.

• Brand Name: PROTECTIV PLUS SAFETY IV CATHETER ANGIOCATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL; southington CT 06489
• MDR Report Key: 7818813
• MDR Text Key: 118528859
• Report Number: MW5079411
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071187
• UDI-Public: 10351688071187
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/17/2021
• Device Model Number: 3060
• Device Catalogue Number: 3060
• Device Lot Number: 3636342
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage