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U.S. Department of Health and Human Services

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

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BD BD INSTYLE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 381423
Device Problems Material Integrity Problem (2978); Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 01/13/2022
Event Type  malfunction  
Event Description
Change in equipment condition; nurses report catheters do not smoothly slide off of needle. Current catheters have a "gritty" feel when the catheter slides over the needle. Does not advance smoothly.
 
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Brand NameBD INSTYLE AUTOGUARD
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 Key13584005
MDR Text Key285995017
Report Number13584005
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 Other Health Care Professional
Type of Report Initial
Report Date 02/07/2022,01/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number381423
Device Catalogue Number381423
Device Lot Number1238769
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/07/2022
Date Report to Manufacturer02/23/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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