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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 SINGLE PORT INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM SINGLE PORT INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383520
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 there was a difficult hub disengagement when using a bd nexiva¿ closed iv catheter system single port. There was no report of exposure, injury or medical intervention.
 
Event Description
It was reported that there was a difficult hub disengagement when using a bd nexiva¿ closed iv catheter system single port. There was no report of exposure, injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: no sample was returned for evaluation. Dhr review - no issues related to the defect were identified during production. Qn review - no qns were initiated due to issues found in production. Causes of the defect are tooling misalignments during assembly. Without the samples the defect could not be confirmed. The occurrence of this incident does not exceed what is acceptable. The severity is limited and the occurrence is low. No actions will be taken at this time.
 
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Brand NameBD NEXIVA¿ CLOSED IV CATHETER SYSTEM SINGLE PORT
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7492246
MDR Text Key107697316
Report Number1710034-2018-00220
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903835201
UDI-Public00382903835201
Combination Product (y/n)N
PMA/PMN Number
K161777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 08/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2020
Device Catalogue Number383520
Device Lot Number7192532
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/07/2018 Patient Sequence Number: 1
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