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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD NEXIVA DUAL PORT DEVICE; INTRAVASCULAR CATHETER
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BECTON DICKINSON UNSPECIFIED BD NEXIVA DUAL PORT DEVICE; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problems Leak/Splash (1354); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/09/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that leakage occurred with a unspecified bd nexiva dual port device.The following information was provided by the initial reporter, "when flushing nexiva, it is very difficult to clear the line with the dual port.As you flush one side of the y port, liquid then flows up the other side and keeps happening unless you connect two posiflush and flush at the same time.This is happening on every nexiva dual port and only becomes evident when you are using a liquid that isn't transparent.This resulted in a bit of muscle relaxation drug being flushed in to a child.".
 
Manufacturer Narrative
H.6.Investigation summary bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.  our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that leakage occurred with a unspecified bd nexiva dual port device.The following information was provided by the initial reporter, "when flushing nexiva, it is very difficult to clear the line with the dual port.As you flush one side of the y port, liquid then flows up the other side and keeps happening unless you connect two posiflush and flush at the same time.This is happening on every nexiva dual port and only becomes evident when you are using a liquid that isn't transparent.This resulted in a bit of muscle relaxation drug being flushed in to a child.".
 
Manufacturer Narrative
The changes are the following: b.5.Describe event or problem: it was reported that an incomplete flush occurred with a unspecified bd nexiva dual port device.The following information was provided by the initial reporter, "when flushing nexiva, it is very difficult to clear the line with the dual port.As you flush one side of the y port, liquid then flows up the other side and keeps happening unless you connect two posiflush and flush at the same time.This is happening on every nexiva dual port and only becomes evident when you are using a liquid that isn't transparent.This resulted in a bit of muscle relaxation drug being flushed in to a child." f.10 device codes: 2964 h3 other text : see h.10.
 
Event Description
It was reported that an incomplete flush occurred with a unspecified bd nexiva dual port device.The following information was provided by the initial reporter, "when flushing nexiva, it is very difficult to clear the line with the dual port.As you flush one side of the y port, liquid then flows up the other side and keeps happening unless you connect two posiflush and flush at the same time.This is happening on every nexiva dual port and only becomes evident when you are using a liquid that isn't transparent.This resulted in a bit of muscle relaxation drug being flushed in to a child.".
 
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Brand Name
UNSPECIFIED BD NEXIVA DUAL PORT DEVICE
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key9900288
MDR Text Key186866319
Report Number2243072-2020-00523
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 04/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Date Manufacturer Received03/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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