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U.S. Department of Health and Human Services

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

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BECTON, DICKINSON AND COMPANY INSYTE-N AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 381411
Device Problem Material Frayed (1262)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/14/2019
Event Type  malfunction  
Event Description
Attempted lab draws two times from patient using bd insyte-n autoguard 24ga x 0.56in catheter.Both catheters frayed/splintered inside the patient.This immediately stopped both lab draws and forced more pokes to the patient.Both catheters came from the same lot.
 
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Brand Name
INSYTE-N 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 Key8955138
MDR Text Key156310077
Report Number8955138
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 08/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number381411
Device Catalogue Number381411
Device Lot Number9024526
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/15/2019
Event Location Hospital
Date Report to Manufacturer09/03/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age30 DA
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