• 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. INSYTE AUTOGUARD WINGED BL 22GA X 1.0IN 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. INSYTE AUTOGUARD WINGED BL 22GA X 1.0IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381523
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0279793, medical device expiration date: 2023-09-30, device manufacture date: (b)(6) 2020. Medical device lot #: 0314415, medical device expiration date: 2023-10-31, device manufacture date: (b)(6) 2020. Medical device lot #: 1054321, medical device expiration date: 2024-01-31, device manufacture date: (b)(6) 2021. 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 that insyte autoguard winged bl 22ga x 1. 0in needle went through the catheter. The following information was provided by the initial reporter: it was reported by the distributor that the catheters do not thread correctly and the needle went through the catheter. Reported issue: we have been having issues with our 22g iv catheters not threading correctly. We have had to stick people a second time due to iv's not threading. When the nurse removes the iv the needle actually went through the middle of the cath when threading. We have done several things here to troubleshoot and try to prevent this but we are still getting this issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINSYTE AUTOGUARD WINGED BL 22GA X 1.0IN
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key12202546
MDR Text Key263378663
Report Number1710034-2021-00597
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,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381523
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-