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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 Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2017
Event Type  malfunction  
Manufacturer Narrative
Results: one used sample and one unused sample were received for evaluation by our quality engineer team. Upon examination, the used unit was partially retracted. Through testing, both units were successfully disengaged with the cannula staying locked by the v-clip as intended. A luer-lok syringe was attached and flushed through the unit, all connections were secure and no leakage was observed. A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defects. Conclusion: the root cause of the defect was not determined during the investigation as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that the safety locking mechanism of the bd nexiva¿ closed iv catheter system did not lock. There was no report of injury or medical intervention.
 
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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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7158048
MDR Text Key250774849
Report Number1710034-2017-00502
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835394
UDI-Public30382903835394
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Catalogue Number383539
Device Lot Number6299940
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/02/2018 Patient Sequence Number: 1
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