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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC ANGIOCATH CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM LESS THAN 30 DAYS

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC ANGIOCATH CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 382533
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2018
Event Type  malfunction  
Event Description
A 20 gauge bd iv catheter was going to be used on a pre-op patient when the rn noted a burr on the side of the plastic portion of the angiocath. The product was not used on the patient.
 
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Brand NameBD INSYTE AUTOGUARD BC ANGIOCATH
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
sandy UT 84070
MDR Report Key7518204
MDR Text Key108610642
Report NumberMW5077244
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 Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Catalogue Number382533
Device Lot Number7240674
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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