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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA DIFFUSICS; CATHETER, INTRAVASCULAR THERAPEUTIC, SHORT-TERM

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BECTON DICKINSON BD NEXIVA DIFFUSICS; CATHETER, INTRAVASCULAR THERAPEUTIC, SHORT-TERM Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Extravasation (1842); Hemorrhage/Bleeding (1888)
Event Date 01/20/2018
Event Type  Injury  
Event Description
A (b)(6) seen in ed and found to have splenic hemorrhage.A 20 g diffusics catheter to right forearm was placed.Pt was taken emergently to operating room.Received normal saline and blood products through right iv site.After procedure, right arm was untucked from drape and found to have significant extravasation.Underwent right forearm fasciotomy for compartment syndrome.
 
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Brand Name
BD NEXIVA DIFFUSICS
Type of Device
CATHETER, INTRAVASCULAR THERAPEUTIC, SHORT-TERM
Manufacturer (Section D)
BECTON DICKINSON
sandy UT 84070
MDR Report Key7237757
MDR Text Key98993913
Report NumberMW5075018
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 Nurse
Type of Report Initial
Report Date 01/31/2018
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/01/2018
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) Other;
Patient Age50 YR
Patient Weight57
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