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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD NEXIVA DIFFUSICS CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BD BD NEXIVA DIFFUSICS CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 383592
Device Problems Sticking (1597); Physical Resistance (2578); Flare or Flash (2942)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2017
Event Type  malfunction  
Event Description
The nurse stated she inserted the angiocath and received an initial flash. When she advanced the needle and catheter, she did not get blood return. She then removed the needle completely and attempted to float the catheter in further. When this did not work, she attempted to remove the catheter. She said it felt like it was stuck on something, and when she removed it, she noticed the catheter was shorter than when she inserted it. Dr. Was notified, and an x-ray confirmed a 1. 1 cm piece of angiocath remained in the patient's left arm. Per dr, no additional follow-up or procedures were required. Manufacturer response for angiocath 20 gauge 1. 00 in (1. 1mm x 25 mm), bd nexiva diffusics (per site reporter). Device will be sent to manufacturer for investigation and analysis.
 
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Brand NameBD NEXIVA DIFFUSICS
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BD
one becton drive
franklin lakes NJ 07417
MDR Report Key7141897
MDR Text Key95621188
Report Number7141897
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2017
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model Number383592
Device Catalogue Number383592
Device Lot Number7241693
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/21/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer11/21/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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