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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD¿ INSYTE-N AUTOGUARD PERIPHERAL VASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD¿ INSYTE-N AUTOGUARD PERIPHERAL VASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 11/06/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. 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 one baby had staph aureus at the site and the baby¿s blood was also positive for staph aureus while using unspecified bd¿ insyte-n autoguard.
 
Event Description
It was reported one baby had staph aureus at the site and the baby¿s blood was also (b)(6) for staph aureus while using unspecified bd insyte-n autoguard.
 
Manufacturer Narrative
Bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Bd was not able to duplicate or confirm the customer¿s indicated failure.
 
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Brand NameBD¿ INSYTE-N AUTOGUARD
Type of DevicePERIPHERAL VASCULAR 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
8015652845
MDR Report Key8113134
MDR Text Key128714089
Report Number1710034-2018-00861
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
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,Followup
Report Date 01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/28/2018 Patient Sequence Number: 1
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