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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD NEXIVA, BD Q-SYTE CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BECTON, DICKINSON AND COMPANY BD NEXIVA, BD Q-SYTE CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 383536
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/17/2018
Event Type  malfunction  
Event Description
Register nurse was inserting an iv into the underside of the patient's right arm, the needle went into the vein, the tubing filled with blood and when withdrawing the needle it punctured through the plastic catheter just outside of the patient's skin. Blood began spurting out at the punctured site of the catheter. I quickly put gauze on it and withdrew the entire device. Luckily the plastic cannula did not break off inside patient's vein. I saved the defective iv in a biohazard bag, given to patient safety officer, manufacturer notified, they are going to send a container to obtain defective device for review. Manufacturer response for bd nexiva 20g iv, bd nexiva (per site reporter). They will send a container for collection of defective device.
 
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Brand NameBD NEXIVA, BD Q-SYTE
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
9450 south state street
sandy UT 84070
MDR Report Key7532801
MDR Text Key108887666
Report Number7532801
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 Patient
Type of Report Initial
Report Date 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Model Number383536
Device Catalogue Number383536
Device Lot Number8031857
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/17/2018
Event Location Hospital
Date Report to Manufacturer05/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/22/2018 Patient Sequence Number: 1
Treatment
NO
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