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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
Model Number 383532
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2022
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that the bd nexiva¿ closed iv catheter system leaked/contrast spilled onto the scanner. The following information was provided by the initial reporter : "there have been multiple repeat scans due to incompatibility issues with the power injector. In addition, we¿ve had contrast spilling onto the scanner which can lead to scanner downtimes. ".
 
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Brand NameBD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15186204
MDR Text Key303941245
Report Number1710034-2022-00426
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835325
UDI-Public30382903835325
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number383532
Device Catalogue Number383532
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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