• 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 INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCUALR 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 INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCUALR CATHETER Back to Search Results
Model Number 381834
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 08/10/2022
Event Type  Injury  
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd insyte¿ autoguard¿ shielded iv catheter an allergic reaction required antibiotics and lab testing.There was no report of patient impact.The following information was provided by the initial reporter: verbatim: i recently spent time in hospital and had to have iv needles.I reacted three times at site of where needle was.Have you ever had any one react to plastic in needle before? the first iv was put in the ambulance.Two days after i woke up with a lot pain in arm and having trouble to move it.The area about 4 inches by six inches very red.The vein was about size pencil in diameter and hard.I had to take antibiotics and hot and cold compresses.They removed it and put another one below it.Two days later it started to get very red as well.Then several days later when i was at a different hospital another iv was started in opposite arm.Two days and it started to turn red.This leads me to think that there is something in the product that i am allergic to.The doctor sent the 2nd one to lab to culture it.Nothing showed in the specimen.
 
Manufacturer Narrative
H.6.Investigation summary: the photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the actual product involved may provide clarification as to the cause for the reported failure.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 insyte¿ autoguard¿ shielded iv catheter an allergic reaction required antibiotics and lab testing.There was no report of patient impact.The following information was provided by the initial reporter: verbatim: i recently spent time in hospital and had to have iv needles.I reacted three times at site of where needle was.Have you ever had any one react to plastic in needle before? the first iv was put in in the ambulance.Two days after i woke up with a lot pain in arm and having trouble to move it.The area about 4 inches by six inches very red.The vein was about size pencil in diameter and hard.I had to take antibiotics and hot and cold compresses.They removed it and put another one below it.Two days later it started to get very red as well.Then several days later when i was at a different hospital another iv was started in opposite arm.Two days and it started to turn red.This leads me to think that there is something in the product that i am allergic to.The doctor sent the 2nd one to lab to culture it.Nothing showed in the specimen.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of Device
INTRAVASCUALR 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 Key15351158
MDR Text Key299270247
Report Number1710034-2022-00470
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818341
UDI-Public00382903818341
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date08/31/2024
Device Model Number381834
Device Catalogue Number381834
Device Lot Number1264046
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/10/2022
Initial Date FDA Received09/02/2022
Supplement Dates Manufacturer Received10/05/2022
Supplement Dates FDA Received10/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-