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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON 22G BD INSYTE AUTOGUARD BC CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BECTON DICKINSON 22G BD INSYTE AUTOGUARD BC CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problems Retraction Problem (1536); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
One 22g bd insyte autoguard bc was bent and not used on the patient. Two others did not retract the needle correctly. Instead, when the rn hit the retract button, it pulled out both the needle and the plastic catheter that normally sits in the vein. Fda safety report id# (b)(4).
 
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Brand Name22G BD INSYTE AUTOGUARD BC
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key11385019
MDR Text Key234041800
Report NumberMW5099653
Device Sequence Number1
Product Code FOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 02/24/2021
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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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