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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 - DUAL PORT 20 GA 1.00 IN; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383536
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2022
Event Type  malfunction  
Event Description
It was reported while using bd nexiva¿ closed iv catheter system - dual port 20 ga 1.00 in the safety mechanism didn't disengage.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: safety mechanism malfunctioned.2 incidents from same lot number on same item number when safety malfunctioned.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 25-oct-2022.H.6.Investigation summary: our quality engineer inspected the samples submitted for evaluation.The complaint that the safety mechanism malfunctioned could not be confirmed from an analysis of the returned samples.Twenty-one sealed 20g nexiva devices and one shielded needle from lot #2202381 were returned for investigation.The needle from the used sample had been retracted and locked within the tip shield.The used nexiva device was not fully returned for investigation; therefore, it could not be determined if the catheter or adapter contributed to the reported malfunction.A functional test of the sealed units revealed nothing remarkable.No defects or potential contributing factors of the reported event were identified on the returned samples.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported while using bd nexiva¿ closed iv catheter system - dual port 20 ga 1.00 in the safety mechanism didn't disengage.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: safety mechanism malfunctioned.2 incidents from same lot number on same item number when safety malfunctioned.2 incidents from same lot number on same item number when safety malfunctioned.
 
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Brand Name
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN
Type of Device
INTRAVASCULAR 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15667103
MDR Text Key306809267
Report Number1710034-2022-00622
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903835362
UDI-Public00382903835362
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383536
Device Lot Number2202381
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/29/2022
Initial Date FDA Received10/25/2022
Supplement Dates Manufacturer Received11/30/2022
Supplement Dates FDA Received12/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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