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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL PROTECTIV PLUS SAFETY IV CATHETER; CATHETER, INTRAVASCULAR
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SMITHS MEDICAL PROTECTIV PLUS SAFETY IV CATHETER; CATHETER, INTRAVASCULAR Back to Search Results
Model Number 3066
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Cellulitis (1768); Erythema (1840); Swelling (2091)
Event Date 04/17/2018
Event Type  Injury  
Event Description
Pt was admitted to hospital on (b)(6) 2018 with complaints of swelling and redness to right forearm, presumed to be cellulitis due to an iv infiltration.Pt had been treated with hot packs and antibiotics on an outpatient basis but a fever developed and pt came to the ed for further evaluation.On (b)(6) 2018 peripheral iv started with 20 ga 1 1/4" iv catheter, one attempt, and infused until removal.Peripheral iv removed on (b)(6) 2018 following rn process for iv removal without complication.Pt discharged to home.Iv site without bleeding, redness, or swelling.Iv catheter checked for integrity upon removal per rn.On (b)(6) 2018 pt went to surgery for right cephalic vein excision under general anesthesia.
 
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Brand Name
PROTECTIV PLUS SAFETY IV CATHETER
Type of Device
CATHETER, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL
southington CT 06489
MDR Report Key7463902
MDR Text Key106791498
Report NumberMW5076737
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 Other Caregivers
Type of Report Initial
Report Date 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number3066
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/25/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
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