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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & COMPANY BD INSYTE AUTOGARD 22GA 1.00IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

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BECTON, DICKINSON & COMPANY BD INSYTE AUTOGARD 22GA 1.00IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM Back to Search Results
Model Number REF 381423
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2017
Event Type  Injury  
Event Description
A (b)(6) female admitted to the emergency department on (b)(6) 2017 at 13:34 and admitted to the inpatient setting on (b)(6) 2017 at 20:54. On (b)(6) 2017 21:54, nurse notified physician that patient reported dislodged iv while showering and that the catheter was not found (patient thought it was retained). Surgical resident documented in assessment that patient stated that when nurse flushed iv she felt a pop within the vein.
 
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Brand NameBD INSYTE AUTOGARD 22GA 1.00IN
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
Manufacturer (Section D)
BECTON, DICKINSON & COMPANY
franklin lakes NJ 07417
MDR Report Key6883270
MDR Text Key87043024
Report NumberMW5072257
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2020
Device Model NumberREF 381423
Device Lot Number7089529
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? 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

Patient Treatment Data
Date Received: 09/20/2017 Patient Sequence Number: 1
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