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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL PROTECTIVE PLUS SAFETY IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT

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SMITHS MEDICAL PROTECTIVE PLUS SAFETY IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT Back to Search Results
Model Number
Device Problem Component Missing (2306)
Patient Problems Hemorrhage/Bleeding (1888); Infiltration into Tissue (1931)
Event Date 06/04/2018
Event Type  Injury  
Event Description
A (b)(6) female presented to ed with iv place. On (b)(6) 2018 at approximately 1530 eeg tech was preparing patient for eeg noticed some blood at the iv site and called the rn to assess the iv site. Rn discontinued iv due to infiltration and upon inspection of the catheter noticed the tip was missing. Us confirmed the iv catheter tip to be lodged in the basilic vein of the left forearm. Vascular surgery was consulted and surgery for removal of the catheter tip is scheduled for (b)(6) 2018. The portion of the product that was removed from the patient has been sequestered by materials management. Manufacturer has been notified.
 
Event Description
Add'l info received from reporter on (b)(6) 2018 for report mw5077711.
 
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Brand NamePROTECTIVE PLUS SAFETY IV CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT
Manufacturer (Section D)
SMITHS MEDICAL
sandy UT 84070
MDR Report Key7586330
MDR Text Key110787274
Report NumberMW5077711
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,Followup
Report Date 06/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number
Device Catalogue Number3065
Device Lot Number
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

Patient Treatment Data
Date Received: 06/08/2018 Patient Sequence Number: 1
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