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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 383532
Device Problems Physical Resistance (2578); Device Operates Differently Than Expected (2913); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/10/2018
Event Type  malfunction  
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 that the safety mechanism failed to work correctly on a bd nexiva¿ closed iv catheter system as the mechanism was found to be "very stiff to pull" and made a "grinding/sound feeling. " there was no report of exposure, serious injury, or medical intervention.
 
Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.
 
Event Description
It was reported with the use of the bd nexiva¿ closed iv catheter system there was an issue with leakage. It was stated ¿after the device was used on the patient, blood leaked. The leaked point is unknown however it must be between the wings and the extube. ¿ there was no report of injury or further 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
MDR Report Key7562015
MDR Text Key109907720
Report Number1710034-2018-00246
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835325
UDI-Public30382903835325
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 09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2020
Device Catalogue Number383532
Device Lot Number7290663
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/01/2018 Patient Sequence Number: 1
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