• 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 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 SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number 381823
Device Problems Retraction Problem (1536); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2021
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 before use of the bd¿ insyte autoguard shielded iv catheter the needle would not retract and the needle broke/detached. This event occurred 3 times. The following information was provided by the initial reporter. The customer stated: "the needle did not retracted, it stayed inside the protective plastic cap. In other case, the needle passed through the device. Once the blister is opened, the needle is separated from the rest of the product. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12667087
MDR Text Key277712408
Report Number1710034-2021-00901
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381823
Device Catalogue Number381823
Device Lot Number1049357
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-