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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC PRO WINGED, 20G X 1.00" INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC PRO WINGED, 20G X 1.00" INTRAVASCULAR CATHETER Back to Search Results
Model Number 392633
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2022
Event Type  malfunction  
Event Description
It was reported while using bd insyte autoguard bc pro winged, 20g x 1. 00 there was an issue of leakage. The following information was provided by the initial reporter: "the anesthesiologist was putting an iv in my wife's arm, i heard her say this thing made a mess, and it wasn't supposed to do that. Blood got all over and the dr. Said she expected the valve to close. This happened in the pre-op room, and there was nothing out of the ordinary from what i could tell. ".
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
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Brand NameBD INSYTE AUTOGUARD BC PRO WINGED, 20G X 1.00"
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15135601
MDR Text Key302286939
Report Number1710034-2022-00404
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903926336
UDI-Public00382903926336
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number392633
Device Catalogue Number392633
Device Lot Number2082792
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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