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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 18 G X 1.25 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 18 G X 1.25 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383539
Device Problem Detachment Of Device Component (1104)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 07/12/2017
Event Type  malfunction  
Manufacturer Narrative
Results: a dhr review was performed on lot number 5156922. Per review of the dhr it was concluded that all required challenges samples and testing was performed per specifications, in accordance with the in-process sampling plans. Per review it was noted that there were no related reject activity findings throughout the build of this lot that would impact upon the quality of the product. Conclusions: confirmation of the defect stated in the pr could not be identified or confirmed and cause could not be determined, as the unit described in the product incident report was not returned for evaluation and testing. Therefore, there was no physical/mechanical evidence to confirm or to support manufacturing process related issues for the defects stated in the pir. This incident is indeterminate. Corrective action project / capa (#): no sample was returned for evaluation and testing; therefore, a root cause could not be established. Severity is limited and occurrence is low. A formal corrective action will not be initiated at this time. Customer complaint trends are evaluated on a monthly basis. If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Udi#: (b)(4).
 
Event Description
It was reported by a consumer there were instances where the tubing inadvertently gets caught in something or the patient pulls at the tubing and the tubing is pulled from the 18 g x 1. 25 in. (1. 3 mm x 31 mm) bd nexiva¿ closed iv catheter system. This allows the vein to free flow out the catheter hub and not only causes a bloody mess, but has serious implications for patient safety. No injury or medical interventions reported.
 
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Brand Name18 G X 1.25 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTERVASCULAR 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 Key6753105
MDR Text Key254653123
Report Number1710034-2017-00120
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2018
Device Catalogue Number383539
Device Lot Number5156922
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 Received07/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2015
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: 07/29/2017 Patient Sequence Number: 1
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