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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383539
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2018
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 the push tab fell off a bd nexiva¿ closed iv catheter system after insertion.There was no report of exposure, injury, or medical intervention.
 
Manufacturer Narrative
No sample available for investigation.Photograph was provided for investigation.Photographs displayed 2 actual samples.One device for (b)(4) and the other for (b)(4).Device/batch history record review findings: the lot was manufactured on nexiva line 1 from 29mar18 through 4apr18.All challenges were successful.Set-up and in process samples including (but not limited to) machine caused damaged were performed at various stages during the manufacturing process and all passed per specification.Although units were not returned; a photo was provided for observation of this incident which revealed the following: there was a top web (tyvek lid) from a package from lot 8087800.There were two units of which both revealed to have had the needle pull through the tip shield.There were traces red fluid in area through one unit and traces of media present in areas throughout the second unit.Confirmed that both units in the photo demonstrated that the tip shield did not safeguard against an accidental needle stick.Root cause: relationship of device to the reported incident is manufacturing.Comment: the lot number associated with this incident is under global (b)(4) for safety shield activation failure.The root cause and corrective actions are currently being investigated by the correspondent team.(b)(4).This is an issue with the safety feature of the device.Although occurrence is low and all reported incidents thus far have limited severity (contaminated needle stick injury with no known blood borne pathogen), there is the potential for higher severity end user effects.A capa project has been opened to address this incident.
 
Event Description
It was reported that the push tab fell off a bd nexiva¿ closed iv catheter system after insertion.There was no report of exposure, injury, or medical intervention.
 
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Brand Name
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7636530
MDR Text Key112436448
Report Number1710034-2018-00371
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835394
UDI-Public30382903835394
Combination Product (y/n)N
PMA/PMN Number
K111366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 09/26/2018
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? Yes
Device Operator Other
Device Expiration Date02/28/2021
Device Catalogue Number383539
Device Lot Number8087800
Initial Date Manufacturer Received 06/12/2018
Initial Date FDA Received06/25/2018
Supplement Dates Manufacturer Received06/12/2018
Supplement Dates FDA Received09/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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