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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 381423
Device Problem Material Separation (1562)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 06/20/2022
Event Type  Injury  
Manufacturer Narrative
A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter broke off inside the patient. The following information was provided by the initial reporter: the tip of the catheter discarded was missing and searched the floor and surrounding area, sent the patient to imaging to see if it broke off in the patient. The patient was evaluated at local imaging center and then referred to the local emergency department for what appeared to be a foreign body in the patient¿s pulmonary artery.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15070437
MDR Text Key296287862
Report Number1710034-2022-00375
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903814237
UDI-Public00382903814237
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 08/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381423
Device Catalogue Number381423
Device Lot Number1355613
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2021
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: 07/20/2022 Patient Sequence Number: 1
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