• 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

  • 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 Back to Search Results
Catalog Number 383531
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943); Local Reaction (2035)
Event Date 09/03/2018
Event Type  Injury  
Manufacturer Narrative
Device expiration date: unknown. Device manufacture date: unknown. (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 that a bd nexiva¿ closed iv catheter system had caused an allergic reaction. The following was reported by the customer, "a patient who was receiving iv clindamycin and flucloxacillin seems to be reacting to cannulae at present. Within 24 hrs of a cannula being insert a red inflamed area appears just at the insertion site. The patient was recannulated at least every 24 hrs and so had multiple sites on both arms as the nurses thought he had phlebitis at the sites. There are no other signs of reaction anywhere else, the sites are not painful just itchy. On saturday night they decided to switch the patient to oral antibiotics and removed all cannulae. Within 12 hrs all areas where the cannulae had been had returned to normal expect for one area on his left arm. ".
 
Manufacturer Narrative
No samples or photos were provided for observation and/or testing of this incident. Dhr and sap (qn) reviews; were not conducted because a lot number was not provided for this incident. Without units or photos provided for observation and/or testing of this incident the alleged defect of irritation/inflammation could not be identified nor confirmed and a definite root cause could not be established.
 
Event Description
It was reported that a bd nexiva closed iv catheter system had caused an allergic reaction. The following was reported by the customer, "a patient who was receiving iv clindomycin and flucloxacillin seems to be reacting to cannulae at present. Within 24hrs of a cannula being insert a red inflamed area appears just at the insertion site. The patient was recannulated at least every 24hrs and so had multiple sites on both arms as the nurses thought he had pheblitis at the sites. There are no other signs of reaction anywhere else, the sites are not painful just itchy. On saturday night they decided to switch the patient to oral antibiotics and removed all cannulae. Within 12hrs all areas where the cannulae had been had returned to normal expect for one area on his left arm. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of DeviceIV CATHETER SYSTEM
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7936294
MDR Text Key122788467
Report Number1710034-2018-00671
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835318
UDI-Public30382903835318
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 11/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number383531
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/04/2018 Patient Sequence Number: 1
-
-