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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 BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381044
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident. Examination of the product involved may provide clarification as to the cause for the reported failure. A device history record review showed no non-conformances associated with this issue during the production of this batch. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported 4 bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology had issues with needle retraction. The following information was provided by the initial reporter, translated from (b)(6): "safety function did not work even when the button was pressed".
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key12737467
MDR Text Key279574571
Report Number1710034-2021-00932
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2021
Device Catalogue Number381044
Device Lot Number8304587
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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