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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 WITH BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER Back to Search Results
Model Number 382512
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Hepatitis (1897); Nausea (1970)
Event Date 07/27/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that the patient had an allergic reaction when the bd insyte¿ autoguard¿ bc shielded iv catheter with blood control technology was used on them to perform a naturopath infusion of vitamins, and sent to the er as a result. Symptoms developed from "30 minutes to 24 hours" after the infusion, and included "flu-like symptoms, diarrhea, nausea, and hepatitis". The patient has reportedly recovered from the incident. This complaint was created to capture the 1st of 2 related incidents. The following information was provided by the initial reporter: "six patients presented to a local emergency department within 24 hours or receiving an infusion of vitamins from a naturopath. They presented with various degrees of symptoms including flu-like symptoms, diarrhea, nausea and hepatitis. All patients who received this treatment were then interviewed and 17 of the 18 developed symptoms from 30 minutes to 24 hours after the infusion. All have recovered. The investigation expanded to include another city in which this naturopath practiced, and more cases were identified with similar symptom complex and timing. ".
 
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Brand NameBD INSYTE AUTOGUARD BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY
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 Key10419114
MDR Text Key210225768
Report Number1710034-2020-00522
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number382512
Device Catalogue Number382512
Device Lot Number9213332
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 Received07/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2019
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: 08/18/2020 Patient Sequence Number: 1
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