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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 SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381023
Device Problems Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter phone#: (b)(6). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter exhibited flow restriction during use, and that another catheter had foreign matter attached to the outside of the catheter, the foreign matter was described as " an outgrowth". No serious injury or medical intervention was reported.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ BC 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
8015652845
MDR Report Key7802734
MDR Text Key118000752
Report Number1710034-2018-00612
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2020
Device Catalogue Number381023
Device Lot Number7334856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/30/2017
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: 08/21/2018 Patient Sequence Number: 1
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