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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 INTRAVENOUS CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVENOUS CATHETER Back to Search Results
Catalog Number 383522
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Laceration(s) (1946)
Event Date 10/19/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: according the customer information per ¿other¿ defect condition, the sample received was analyzed visually. It did not show any flash or plastic excess underneath stabilization platform and septum of device which could cause a lacerations on skin. During the visual inspection this sample showed a good visual condition without hurt on the area of device mentioned before. Bd was unable to duplicate or confirm the customer¿s indicated failure mode because the defect was not evident in the visual inspection of the returned sample. A review of the device history and manufacturing records revealed no related issues related to damaged components. We could not confirm a specific root cause for this issue since the actual sample received didn¿t show any issue related to the incident reported. Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.
 
Manufacturer Narrative
Date of event: unknown. 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 with the use of the nexiva 22 ga x 1. 00in sp that there are grooves underneath the stabilization platform and septum that are causing lacerations on frail skin. There was no report of injury or medical intervention.
 
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Brand NameBD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVENOUS 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 Key7022582
MDR Text Key246698069
Report Number1710034-2017-00318
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K102520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue Number383522
Device Lot Number7177667
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2017
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: 11/10/2017 Patient Sequence Number: 1
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