• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383539
Device Problem Fail-Safe Design Failure (1222)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2018
Event Type  malfunction  
Manufacturer Narrative
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 that there was a safety shield activation failure while using a bd nexiva¿ closed iv catheter system safety device. There was no report of exposure, injury, or medical intervention.
 
Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident. Observations and testing could not be performed because units were not provided for investigation. A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications. The lot number 8087800 is currently being investigated further for review of the safety shield activation failure. Investigation conclusion: the root cause was related to manufacturing. This is an issue with the safety feature of the device. Although occurrence is low and all reported incidents thus far have limited severity (contaminated needle stick injury with no known blood borne pathogen), there is the potential for higher severity end user effects. Capa #(b)(4) has been opened to address this incident. Capa (b)(4) problem statement: the tip shield did not properly capture the tip of some nexiva 18 ga needle between the v-clip and washer. Instead, due to the failure mode of bump out of specification (small or missing), the needle pulled through the washer and allowed the gray tip shield to disconnect from the needle assembly. Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted fields: event attributed to: other, device single use?: no, device returned to manufacturer: no.
 
Event Description
It was reported that there was a safety shield activation failure while using a bd nexiva¿ closed iv catheter system safety device. There was no report of exposure, injury, or medical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key7659616
MDR Text Key113284043
Report Number1710034-2018-00377
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K111366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 08/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number383539
Device Lot Number8087800
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/03/2018 Patient Sequence Number: 1
-
-