Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD INSYTE AUTOGUARD; 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
 

BD BD INSYTE AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 382512
Device Problems Difficult to Insert (1316); Extrusion (2934)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2017
Event Type  malfunction  
Event Description
An elderly patient arrived to endoscopy lab for esophagogastroduodenoscopy (egd).Rn attempted iv without success.Upon looking at failed insyte, rn noted a little piece of catheter sticking up.Second rn successfully placed another insyte.Pt sustained additional needle stick.Manufacturer response for insyte, bd insyte aurtogard bc shielded iv catheter (per site reporter): equipment failure reported to manufacturer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD INSYTE AUTOGUARD
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BD
one becton drive
franklin lakes NJ 07417
MDR Report Key7154002
MDR Text Key96031064
Report Number7154002
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/28/2017,12/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number382512
Device Lot Number7031946
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2017
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/28/2017
Event Location Hospital
Date Report to Manufacturer11/28/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/29/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
Patient Age50 YR
Patient Weight109
-
-