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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INSYTE AUTOGUARD 24GA X 0.75 IN OVER THE NEEDLE IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BD INSYTE AUTOGUARD 24GA X 0.75 IN OVER THE NEEDLE IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Lot Number 1144068
Device Problem Difficult to Remove (1528)
Patient Problem Needle Stick/Puncture (2462)
Event Date 10/15/2021
Event Type  malfunction  
Event Description
Insyte autoguard 24ga x 0. 75 in noted to have tighter than normal cap. Difficulty in removing cap resulted in clean needle stick to rn using device. Rn reported that they had noted tighter than usual caps with this device for a couple of days prior to incident. Upon inspection, device noted to have very slight curvature as compared to other devices. Fda safety report id # (b)(4).
 
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Brand NameINSYTE AUTOGUARD 24GA X 0.75 IN OVER THE NEEDLE IV CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BD
MDR Report Key12672405
MDR Text Key278085649
Report NumberMW5104806
Device Sequence Number1
Product Code FOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1144068
Was Device Available for Evaluation? Device Returned to Manufacturer
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

Patient Treatment Data
Date Received: 10/20/2021 Patient Sequence Number: 1
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