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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 382533
Device Problems Backflow (1064); Fluid Leak (1250); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 8304898. Medical device expiration date: 2021-10-31. Device manufacture date: 2018-11-12. Medical device lot #: 8310640. Medical device expiration date: 2021-10-31. Device manufacture date: 2018-11-06. The customer's address is unknown. Unknown, (b)(6) usa has been used as a default. 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 4 bd insyte¿ autoguard¿ bc shielded iv catheters from lot # 8304898, and 1 catheter from lot # 8310640 had defective valve port plugs that would not engage when pressed, causing blood to back up and leak out during use. The following information was provided by the initial reporter: "health professional called to report that on 5 catheters the valve port plug is not engaging when pressed so blood is backing up and leaking out. ".
 
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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
8015652341
MDR Report Key8565482
MDR Text Key145113993
Report Number1710034-2019-00470
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110443
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 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number382533
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2019
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: 04/30/2019 Patient Sequence Number: 1
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