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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER
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BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Model Number 383552
Device Problem Material Protrusion/Extrusion (2979)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/26/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the bd nexiva¿ closed iv catheter system needle detached from the safety mechanism during use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "needle detached from needle less system, leaving bare needle in rn's hand and plastic piece still attached to catheter".
 
Event Description
It was reported that the bd nexiva¿ closed iv catheter system needle detached from the safety mechanism during use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "needle detached from needle less system, leaving bare needle in rn's hand and plastic piece still attached to catheter".
 
Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: dev.Serviced by a 3rd party? no d10: device available for evaluation? yes.D10: returned to manufacturer on: 2021-03-22 h6: investigation summary a sample was received after the completion of a no sample investigation.The investigation has been updated to reflect the findings.Our quality engineer inspected the sample submitted for evaluation.Bd received a tip shield and washer from a nexiva device.As the tip shield was received without a needle, it can be confirmed that the tip shield failed as its purpose is to contain the needle tip once retraction has occurred.The reported defect was confirmed.No visible signs of damage to the tip shield were observed and the returned components were within specification.Although a specific root cause could not be determined without examining the needle, the defect is most likely attributed to the manufacturing process.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the bd nexiva¿ closed iv catheter system needle detached from the safety mechanism during use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "needle detached from needle less system, leaving bare needle in rn's hand and plastic piece still attached to catheter".
 
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Brand Name
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of Device
INTRAVASCULAR CATHETER
MDR Report Key11103232
MDR Text Key226857940
Report Number9610847-2020-00444
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835523
UDI-Public30382903835523
Combination Product (y/n)N
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup,Followup
Report Date 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Model Number383552
Device Catalogue Number383552
Device Lot Number9324429
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2021
Initial Date Manufacturer Received 12/04/2020
Initial Date FDA Received12/31/2020
Supplement Dates Manufacturer Received02/08/2021
09/01/2021
Supplement Dates FDA Received02/11/2021
09/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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