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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 383512
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2019
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: n/a.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd nexiva¿ closed iv catheter system had a printing defect.This occurred on 6 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: printing defect.Ink was in the package.
 
Manufacturer Narrative
H.6.Investigation: review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed four non-related qn¿s were initiated on the build of this lot that would not impact the outcome of the quality of the product relevant to the defect stated in the pir.Received on 4/11/2019, one unused unit in a sealed package from catalog number 383512, lot number 8310636 and one unused unit in a sealed package with no labeling on the package label.Five photos were submitted for review: photo one displayed two package label, package on top had package label with print and fm and the bottom package was missing the package print.O photo two displayed the two nexiva 22ga units in packaging.The top package had fm.O photo three displayed a closeup of fm on the package.O photo four displayed a closeup of fm o photo five displayed a closeup of fm visual/microscopic evaluation: unit 1 had fm on the package label.O the blue line on the package label was out of alignment.The blue line should be closer to the edge of the package unit 2 was missing the packaging print information o the blue line on the package label was out of alignment the blue line should be closer to the edge of the package comparison between correct alignment and incorrect alignment (the correct position of the colored strip on the package label is along the top edge of the package) photos: based on the evaluation of the submitted photos; the photos displayed fm, missing print and the incorrect alignment of the package top web (label).Which is the same finding as that of the evaluation of the returned unit.The defects foreign matter and label content missing were identified and confirmed with the returned unit.The fm on the package was identified as the ink used for the print on the package label.The package top web (label) was mis-aligned.The correct position of the colored strip on the package label is along the top edge of the package.To fix the alignment issues when the guards are off, the machine will run nor print.The missing print from the package label is was from the machine operator has to wait seven cycles and remove all defective parts from the multivac.The product associated with this incident report was not removed due to human error.The units shown for this incident were packaged during this process and the operator failed to reject them.The top web can become misaligned on the unit package when the top web splice is out of alignment or if the top web breaks at the printer.Furthermore, if the top web breaks at the printer, there will be units that do not contain print once the web is spliced.Operators are required to follow top web splices through the process to ensure the spliced units are rejected by the machine.Additionally in that scenario, they are supposed to ensure that any other print or top web discrepancies are rejected from the machine.
 
Event Description
It was reported that bd nexiva¿ closed iv catheter system had a printing defect.This occurred on 6 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: printing defect.Ink was in the package.
 
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Brand Name
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key8493448
MDR Text Key141456722
Report Number1710034-2019-00390
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835127
UDI-Public30382903835127
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
Report Date 05/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383512
Device Lot Number8310635
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2019
Date Manufacturer Received03/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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