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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383552
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Injury (2348)
Event Date 08/09/2018
Event Type  Injury  
Manufacturer Narrative
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 during use of the bd nexiva¿ closed iv catheter system, that the patient developed complications and the ct indicated air.
 
Event Description
It was reported that during use of the bd nexiva closed iv catheter system, that the patient developed complications and the ct indicated air.
 
Manufacturer Narrative
A device history review was conducted for lot number 7346995, our records show it was manufactured december 2016; it was determined that this is the only instance of an event of this nature occurring in this lot. According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections of packaged goods. Two representative samples were returned by your facility for evaluation. Bd engineers were unable to find evidence to suggest the reported failure mode is related to the nexiva with either sample provided. Inspections of the device included specific inspections of the cannula for damage or deformity, but the devise were found to conform with product specifications. Bd engineers cannot determine the root cause of this event at this time.
 
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Brand NameBD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MDR Report Key7833393
MDR Text Key118784819
Report Number9610847-2018-00285
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835523
UDI-Public30382903835523
Combination Product (y/n)N
PMA/PMN Number
K102520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 10/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2020
Device Catalogue Number383552
Device Lot Number7346995
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/30/2018 Patient Sequence Number: 1
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