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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

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BD BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 382534
Device Problem Defective Device (2588)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 09/22/2019
Event Type  malfunction  
Event Description
Rn stuck the patient with a 20g iv catheter. Upon insertion, i got blood flash, pushed the retract button on the needle and the entire catheter was pulled with the needle, came out of the patient. Patient began bleeding, which was controlled with direct pressure and pressure dressing. Rn stuck the patient for an iv the second time and this catheter began pouring blood out of the catheter hub, which is not supposed to happen according to products function.
 
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Brand NameBD INSYTE AUTOGUARD
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BD
5859 farinon dr ste 200
san antonio TX 78249
MDR Report Key9510751
MDR Text Key172439935
Report Number9510751
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number382534
Device Catalogue Number382534
Device Lot Number9144842
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/16/2019
Event Location Hospital
Date Report to Manufacturer12/23/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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