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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER Back to Search Results
Catalog Number 382533
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Extravasation (1842)
Event Date 08/19/2019
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided. This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences. Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.
 
Event Description
It was reported that the 20g x 1. 00in (1. 1 x 25 mm) insyte autoguard bc experienced infiltration/extravasation during use. The following information was provided by the initial reporter: material no: 382533, batch no: unknown. Since implementation in (b)(6) 2019, they've had 8 documented iv infiltration number of occurrences: 8.
 
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Brand Name20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC
Type of DeviceINTERVASCULAR 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 Key9297510
MDR Text Key177374979
Report Number1710034-2019-01199
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
Report Date 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number382533
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 Received10/24/2019
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: 11/08/2019 Patient Sequence Number: 1
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