• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEE H10 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
 

SEE H10 INTRAVASCULAR CATHETER Back to Search Results
Model Number 382512
Device Problem Insufficient Information (3190)
Patient Problems Diarrhea (1811); Hepatitis (1897); Nausea (1970)
Event Date 07/19/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. Medical device brand name: bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 24ga 0. 75in (0. 7 x 19 mm). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 24ga 0. 75in (0. 7 x 19 mm) was involved with a patient experiencing serious injury in the form of diarrhea, hepatitis, and nausea. It has not been specified whether medical intervention was administered. The following information was provided by the initial reporter: diarrhea, hepatitis, nausea, insufficient information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSEE H10
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12330969
MDR Text Key266867203
Report Number1710034-2021-00713
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number382512
Device Catalogue Number382512
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2021
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

Patient Treatment Data
Date Received: 08/17/2021 Patient Sequence Number: 1
-
-