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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¿ IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381833
Device Problem Retraction Problem (1536)
Patient Problem Needle Stick/Puncture (2462)
Event Date 04/06/2022
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.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ iv catheter's safety mechanism failed to retract the needle and the nurse pricked their finger on it, requiring blood testing per protocol. The following information was provided by the initial reporter, translated from french: "during the insertion of a catheter, when removing the mandrel, one of our nurses tried to activate the catheter safety. However, the mechanism did not work, the chuck did not retract. The patient thought the procedure was over, moved and the nurse pricked her finger with the catheter. ".
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ 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 Key14224617
MDR Text Key290289275
Report Number1710034-2022-00217
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number381833
Device Lot Number1222254
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2021
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: 04/27/2022 Patient Sequence Number: 1
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