• 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 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 BL 22GA X 1.0IN INTRAVASCULAR CATHETER Back to Search Results
Model Number 381823
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Needle Stick/Puncture (2462)
Event Date 04/06/2021
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. A device history record review showed no non-conformances associated with this issue during the production of this batch. Investigation conclusion: 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. Root cause description: the reported defect could not be refuted nor confirmed in the absence of a sample. The root cause cannot be determined.
 
Event Description
It was reported that insyte autoguard bl 22ga x 1. 0in cap was difficult to remove and caused the nurse to receive an injury. The following information was provided by the initial reporter: during the insertion of a peripheral venous line, the nurse on duty found herself in difficulty because she was unable to remove the cap from the catheter. After several attempts, she finally managed to do so, but injured her finger during the removal movement. It seems that the needle of the catheter was bent which prevented the "unblocking". Clinical consequences: the nurse found herself with a finger pierced from one side to the other with the need for surgical management and a 15-day absence from work. Unfortunately, as the defective device was not kept, we are aware that the expertise cannot be performed on the incriminated device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINSYTE AUTOGUARD 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
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 Key11787829
MDR Text Key261740839
Report Number1710034-2021-00380
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818235
UDI-Public00382903818235
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number381823
Device Catalogue Number381823
Device Lot Number0216674
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/03/2020
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: 05/06/2021 Patient Sequence Number: 1
-
-