• 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-N AUTOGUARD WINGEDBD INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

  • 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-N AUTOGUARD WINGEDBD INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 381511
Device Problems Connection Problem (2900); Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 02/16/2021
Event Type  malfunction  
Event Description
Nurse was unable to attach extension set at yellow hub.Nurse thought the hub was cracked.After further investigation it is found that the threading hub was bent but did not inhibit the connection of an extension set at the hub.Device was still functional upon closer review.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD INSYTE-N AUTOGUARD WINGEDBD INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON INFUSION THERAPY SYSTEMS INC.
1 becton drive
franklin lakes NJ 07417
MDR Report Key11462087
MDR Text Key239169357
Report Number11462087
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/03/2021,02/23/2021
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 No Information
Device Model Number381511
Device Catalogue Number381511
Device Lot Number0265013
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2021
Date Report to Manufacturer03/11/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/11/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
-
-