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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 383519
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/25/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 bd nexiva¿ closed iv catheter system there was an issue with tubing defect. There was no report of injury or medical intervention.
 
Manufacturer Narrative
Received one 18ga nexiva unit within an open package from lot number 7286659. The needle-shield assembly was partially disengaged. A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of tubing damaged-defective-other with lot #7286659 regarding (b)(4). Dhr review shows a total of (b)(4) units were manufactured on nexiva line 1 starting on (b)(6) 2017 through (b)(6) 2017. 2 non-related qns (retraction failure) 200713406 and 200713575 were initiated during the production of the lot number associated with this incident. Disposition of the product, root cause and corrective action were applied according to the quality control plan. All other challenge, set-up and in process samples including (but not limited to) correct assembly and part air-water-leak test passed per specification. Visual evaluation of the unit revealed the end of the extension tube was not correctly inserted into the winged adapter port (kinked) and had left a partial gap of tubing out. This condition would cause leakage as experienced by the customer. This defect occurs during the manufacturing process on zone 8 at the adhesive dispense station if the catheter adapter is misaligned during the insertion of the extension tube. Current process controls include routine leak testing after zone 9 as well as a 100% online flow tester in zone 8. 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.
 
Event Description
It was reported with the use of the bd nexiva closed iv catheter system there was an issue with tubing defect. There was no report of injury or 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
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 Key7981723
MDR Text Key124687147
Report Number1710034-2018-00748
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K161777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue Number383519
Device Lot Number7286659
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2017
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: 10/18/2018 Patient Sequence Number: 1
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