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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEE H10 INTRAVASCULAR CATHETER

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SEE H10 INTRAVASCULAR CATHETER Back to Search Results
Model Number 382612
Device Problems Defective Component (2292); Detachment of Device or Device Component (2907); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 07/19/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used. Medical device brand name: bd insyte¿ autoguard¿ bc winged shielded iv catheter blood control technology 24ga 0. 75in. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ bc winged shielded iv catheter blood control technology 24ga 0. 75in experienced device damage while still considered operable, and a catheter that separated from the hub. The following information was provided by the initial reporter: bd insyte autoguard shielded i. V. Catheter with blood control, winged [382612] defective component, detachment of device or device component.
 
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Brand NameSEE H10
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12329096
MDR Text Key266878776
Report Number1710034-2021-00711
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 09/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number382612
Device Catalogue Number382612
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
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

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