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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL PROTECTIV PLUS SAFETY IV CATHETER ANGIOCATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
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.
 
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Brand NamePROTECTIV PLUS SAFETY IV CATHETER ANGIOCATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL
southington CT 06489
MDR Report Key7818813
MDR Text Key118528859
Report NumberMW5079411
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received08/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/17/2021
Device Model Number3060
Device Catalogue Number3060
Device Lot Number3636342
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

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