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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381411
Device Problem Insufficient Information (3190)
Patient Problem Staphylococcus Aureus (2058)
Event Date 01/14/2019
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.
 
Event Description
It was reported that an infant developed (b)(6) at the iv sit from where a 24 g x 0. 56 in. Bd insyte-n¿ autoguard¿ shielded iv catheter was removed. "baby developed (b)(6) in iv site 24 hours after removal. ".
 
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Brand Name24 G X 0.56 IN. BD INSYTE-N¿ 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
8015652341
MDR Report Key8324404
MDR Text Key135677350
Report Number1710034-2019-00163
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 health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date05/31/2020
Device Catalogue Number381411
Device Lot Number7170679
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/19/2017
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: 02/08/2019 Patient Sequence Number: 1
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