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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¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Model Number 381444
Device Problem Material Twisted/Bent (2981)
Patient Problem Perforation of Vessels (2135)
Event Date 03/10/2022
Event Type  malfunction  
Event Description
It was reported bd insyte¿ autoguard¿ shielded iv catheter kinked during use.The following information was provided by the initial reporter: "they are crimping while trying to start the iv and remain crimped when removing the needle.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.Unknown, (b)(6) 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.
 
Manufacturer Narrative
Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.
 
Event Description
It was reported bd insyte¿ autoguard¿ shielded iv catheter kinked during use.The following information was provided by the initial reporter: "they are crimping while trying to start the iv and remain crimped when removing the needle.".
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13964398
MDR Text Key288671614
Report Number1710034-2022-00157
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903814443
UDI-Public30382903814443
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201075
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 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number381444
Device Catalogue Number381444
Device Lot Number1362806
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/28/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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