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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD INSYTE USED 20GA CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BD BD INSYTE USED 20GA CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number BD INSYTE 20 GA
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/12/2021
Event Type  malfunction  
Event Description
Starting and iv and iv hub was not attached to catheter in vein and silver hub from inside of hub in view. Removed from patients vein catheter intact. Bd insyte used 20ga lot number 0302196 expiration date 9/30/23. No harm to patient except another iv stick. Fda safety report id#: (b)(4).
 
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Brand NameBD INSYTE USED 20GA
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BD
MDR Report Key11348229
MDR Text Key232863059
Report NumberMW5099488
Device Sequence Number1
Product Code FOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBD INSYTE 20 GA
Device Lot Number0302196
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

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