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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 382544
Device Problem Component Missing (2306)
Patient Problem Thrombus (2101)
Event Date 02/20/2020
Event Type  malfunction  
Event Description
Patient care technician was removing this patient's iv as he was being discharged.Upon removal, they observed that the tip of the iv was missing a small piece.The physician was called and ordered a ultrasound of the patient's arm to be done.There was no echogenic material seen in the vein but there was a nonocclusive mural thrombus.This iv was placed on [date redacted].We do not know the lot number as the packaging was not saved, but on the dressing which we believe is the original dressing, has the numbers (b)(4) on the tape.
 
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Brand Name
BD INSYTE AUTOGUARD
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key9876945
MDR Text Key184867220
Report Number9876945
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903825448
UDI-Public(01)00382903825448
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number382544
Device Catalogue Number382544
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/21/2020
Event Location Hospital
Date Report to Manufacturer03/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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