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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INSYTE AUTOGUARD BC CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BD INSYTE AUTOGUARD BC CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 382523
Device Problem Physical Resistance (2578)
Patient Problem Pain (1994)
Event Date 06/15/2016
Event Type  malfunction  
Event Description
Patient complained of pain in left wrist where the iv was infusing, it was noted to be in the artery - no flash back, unable to determine the iv was placed into the artery. Anesthesia felt resistance and lowered the iv bag, which allowed blood to rush into the bag. Anesthesia determined iv was in the artery. New iv started. No harm to the patient.
 
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Brand NameINSYTE AUTOGUARD BC
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 Key5976529
MDR Text Key55589382
Report Number5976529
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
Type of Report Initial
Report Date 09/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number382523
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/14/2016
Event Location Other
Date Report to Manufacturer09/14/2016
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/26/2016 Patient Sequence Number: 1
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