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U.S. Department of Health and Human Services

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

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BD BD INSYTE AUTOGUARD CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Lot Number 1230855
Device Problem Mechanical Problem (1384)
Patient Problem Insufficient Information (4580)
Event Date 10/27/2021
Event Type  malfunction  
Event Description
Peripheral iv 20 g of the bd insyte autoguard is malfunctioning for this lot. Have had 6 reported ivs malfunctioning. Staff go to take the cap off and the needle retracts before you even can use it. Fda safety report id# (b)(4).
 
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Brand NameBD INSYTE AUTOGUARD
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BD
MDR Report Key12737978
MDR Text Key280054026
Report NumberMW5105068
Device Sequence Number1
Product Code FOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/28/2021
6 Devices were Involved in the Event: 1   2   3   4   5   6  
0 Patients were Involved in the Event:
Date FDA Received11/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1230855
Was Device Available for Evaluation? No
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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