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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 INTERVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD INTERVASCULAR CATHETER Back to Search Results
Catalog Number 381433
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Phlebitis (2004); Thrombosis (2100)
Event Date 02/07/2019
Event Type  malfunction  
Manufacturer Narrative
Medical 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. The complaint was deemed as mdr reportable therefore a submission will be performed. Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place. This complaint will be closed at this time.
 
Event Description
It has been reported that one 20g x 1. 00in (1. 1 x 25 mm) insyte autoguard has been found causing an allergic reaction during use. The following has been provided by the initial reporter: material no. 381433, batch no. Unknown. It was reported that health professional stated that facility has had 10 reports of phlebitis, thrombo phlebitis or dvt since (b)(6). Verbatim: health professional called and stated facility has had 10 reports of phlebitis, thrombo phlebitis or dvt since (b)(6). Has the dates that patients had the iv's inserted. Inserted and removed (b)(6) 2019. By the time they noticed an issue they weren't recording lot numbers.
 
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Brand Name20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD
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 Key8847946
MDR Text Key153859397
Report Number1710034-2019-00824
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 other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number381433
Device Lot NumberUNKNOWN
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 Received07/16/2019
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: 07/31/2019 Patient Sequence Number: 1
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