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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 WITH DUAL PORT CLOSED IV CATHETER SYSTEM

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT CLOSED IV CATHETER SYSTEM Back to Search Results
Catalog Number 383536
Device Problem Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2017
Event Type  malfunction  
Manufacturer Narrative
Bd received samples from the customer. Examination of the sample found that the drag was coming from interference of the cannula and washer along the length of the cannula. The washer was within specification. A review of the device history record revealed no irregularities during the manufacture of the reported lot number. The defect of difficult disengagement was confirmed though it did not result in failure to retract. An absolute root cause for this incident cannot be determined.
 
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 during use of the bd nexiva¿ closed iv catheter system with dual port there was a ¿gritty/resistance feel¿ when pulling needle back from angiocath. There was no blood flush when starting iv. There was no report of injury or medical intervention.
 
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Brand NameBD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT
Type of DeviceCLOSED IV CATHETER SYSTEM
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 Key7073369
MDR Text Key254971177
Report Number1710034-2017-00444
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2020
Device Catalogue Number383536
Device Lot Number7242997
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2017
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: 11/30/2017 Patient Sequence Number: 1
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