• 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-N AUTOGUARD 24G X 0.56 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-N AUTOGUARD 24G X 0.56 CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number REF 381411
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 03/17/2021
Event Type  malfunction  
Event Description
Found angiocaths with this black substance all from same lot number/expiration. Bd insyte-n autoguard 24g x 0. 56", lot 0275658, exp 2023-09-30; found 13 out of 4 boxes (50 in each box). Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD INSYTE-N AUTOGUARD 24G X 0.56
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BD
MDR Report Key11529579
MDR Text Key241491378
Report NumberMW5100127
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/17/2021
13 Devices were Involved in the Event: 1   2   3   4   5   6   7   8   9   10   11   12   13  
0 Patients were Involved in the Event:
Date FDA Received03/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREF 381411
Device Catalogue NumberREF 381411
Device Lot Number0275658
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-