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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 SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number 381423
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problems Fever (1858); Vomiting (2144)
Event Date 10/21/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter caused the patient's vein to blow, and would not come out until vat was called to remove it. Upon removal, a "slit/puncture" was found in the catheter, and the patient required additional needle procedure for another iv placement. The following information was provided by the initial reporter: "rn went to place iv in patient's left ac, retracted needle and obtained cultures. Vein blew and when this rn went to remove iv catheter, it would not come out. This rn never rethreaded needle into the catheter. Vat called to bedside and removed catheter from patient. When catheter was removed, it has a slit/puncture in it. Catheter and packaging was bagged. Patient and family updated through entire process. " "yes, patient required additional needle procedure for iv placement" "causing fever and vomiting. ".
 
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Brand NameBD INSYTE AUTOGUARD SHIELDED IV CATHETER
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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key10841530
MDR Text Key216313415
Report Number1710034-2020-00728
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381423
Device Catalogue Number381423
Device Lot Number0164707
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/15/2020 Patient Sequence Number: 1
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