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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 383516
Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/23/2018
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 the device disconnecting.It was stated ¿a number of the cannulas had the air vent loose in the packet.Air vent disconnected prior to use.¿ there was no report of injury or further medical intervention.
 
Event Description
It was reported with the use of the bd nexiva¿ closed iv catheter system there was an issue with the device disconnecting.It was stated ¿a number of the cannulas had the air vent loose in the packet.Air vent disconnected prior to use.¿ there was no report of injury or further medical intervention.
 
Manufacturer Narrative
Device/batch history record review was conducted which disclosed the following: lot: 7299731; was built and packaged on nfa line 1 from 27oct2017 through 01nov2017 for the quantity of (b)(4).Review disclosed no indication of the alleged defect as there were no reject activity findings throughout the build of this lot that would impact upon the quality relevant to the defect of the product as stated in the pir.All required challenge samples and testing during the build of the catheters was performed per specifications, in accordance with the in-process sampling plans.Sap (qn) database review subject code was an s1 severity ranking.Review was conducted for this mdr-level a investigation; which disclosed one non-related finished goods qn and no related reject activity findings relevant to the failure as stated in the pir associated with the lot number provided for this incident.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that due to low occurrence and limited severity, current risk is acceptable.Observations and testing could not be performed because units were not provided for investigation.Conclusions: confirmation of the defect as stated in the product incident report, could not be identified or confirmed and cause could not be determined, as the units described in the product incident report were not returned for evaluation and testing.Therefore, there was no physical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir.Relationship of device to the reported incident: design ¿ vent plug/loose/missing: although the defect described in the product incident report was not confirmed or replicated because units were not provided for this incident; the failure of loose/missing vent plug as identified and confirmed with the photo provided for this incident is a known issue.The vent plug is inserted into the luer adapter at a specified force during manufacturing.This is a design issue; after the nexiva product goes through sterilization the fit between the flow plug and luer adapter becomes loose due to material relaxation.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.
 
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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 Key7485832
MDR Text Key107574024
Report Number1710034-2018-00201
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835165
UDI-Public30382903835165
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 08/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2020
Device Catalogue Number383516
Device Lot Number7299731
Was Device Available for Evaluation? No
Date Manufacturer Received04/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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