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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 383536
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2022
Event Type  malfunction  
Event Description
It was reported that the bd nexiva¿ closed iv catheter system experienced damage from the needle inside the catheter. The following information was provided by the initial reporter: after pricking the patient we were unable to remove the device from the needle inside the catheter.
 
Manufacturer Narrative
Investigation summary: there was no sample or photo available to bd for evaluation. Therefore, bd was unable to perform a thorough investigation to verify the reported issue. Since, an investigation could not be performed bd was unable to determine a possible root cause. The manufacturing facility has been notified of this incident and the findings. A review of the device history record was performed and no quality issues were found during production.
 
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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 Key14841393
MDR Text Key303177588
Report Number1710034-2022-00321
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835363
UDI-Public30382903835363
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,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number383536
Device Catalogue Number383536
Device Lot Number1305444
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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