• 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¿ BC SHIELDED IV CATHETER 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 INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number 382533
Device Problem Retraction Problem (1536)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 07/29/2021
Event Type  Injury  
Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident. Examination of the 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. The defect could not be refuted nor confirmed in the absence of a sample. The root cause cannot be determined for an unconfirmed defect.
 
Event Description
It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter the needle partially retracted. The following information was provided by the initial reporter. The customer stated: the needle did not retract and the emt's finger was pricked. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key12709973
MDR Text Key278782960
Report Number1710034-2021-00923
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number382533
Device Catalogue Number382533
Device Lot Number1144503
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/28/2021 Patient Sequence Number: 1
-
-