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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 383516
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: investigation summary: a sample is not available for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. In the event that new, changed, or corrected information is obtained, a supplemental report will be filed. Investigation conclusion: the customer's experience could not be confirmed or reproduced as no sample was received for evaluation and testing. The failure mode of extension tubing separating from the catheter adapter has been identified. The effect of this failure was two or more piv insertions required, per customer verbatim in related (b)(4). Root cause description: the customer's experience could not be confirmed or reproduced as no sample was received for evaluation and testing. Root cause is indeterminate.
 
Event Description
It was reported that the inserter separated from the tubing on a bd nexiva¿ closed iv catheter system during use. Injury and medical intervention are unknown.
 
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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 Key7024902
MDR Text Key92923027
Report Number1710034-2017-00310
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial
Report Date 10/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383516
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2017
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

Patient Treatment Data
Date Received: 11/13/2017 Patient Sequence Number: 1
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