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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BECTON, DICKINSON AND COMPANY BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 381534
Device Problems Break (1069); Detachment Of Device Component (1104); Fluid Leak (1250)
Patient Problems Inflammation (1932); Thrombosis (2100); Foreign Body In Patient (2687)
Event Date 01/11/2017
Event Type  Injury  
Event Description
A 20g iv was placed by the iv nurse in the patient's left forearm without difficulty. Later that evening at approximately 11 pm, her nurse noted the iv was leaking. The iv nurse was contacted to evaluate. The dressing was removed and revealed the iv catheter was severed. The pink luer connector remained, but the rest of the catheter could not be located. The nurse checked the patient's arm, bed, floor and surrounding areas without finding the rest of the catheter. The medical team was notified. An upper extremity duplex revealed focal superficial thrombophlebitis in a superficial left forearm vein associated with an iv catheter, but no evidence of deep vein thrombosis. A vascular surgery consultation was obtained. The patient was taken to the operating room for excision of the left superficial forearm vein foreign body (intravenous catheter). A 1. 5 ¿ 2 cm incision was made over the foreign body and it was easily removed. The foreign body was sent to pathology and no additional material was retained in the vein. The site was irrigated, inspected, closed used 6-0 monocryl, followed by a band-aid.
 
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Brand NameBD INSYTE AUTOGUARD
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton dr.
franklin lakes NJ 07417
MDR Report Key6263136
MDR Text Key65248468
Report Number6263136
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 01/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number381534
Device Catalogue Number381534
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/18/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer01/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/19/2017 Patient Sequence Number: 1
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