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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381923
Device Problems Leak/Splash (1354); Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2021
Event Type  malfunction  
Manufacturer Narrative
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 bd insyte¿ autoguard¿ shielded iv catheter experienced a case of air bubbles in line, and leakage. The following information was provided by the initial reporter: faulty injections due to a sealing problem between the intrabody catheter part of the patient and the external part. Presence of air "bubbles" during the venous return. Passage of the product between these two zones. Description distributor: leakage problem between the intrabody and extrabody catheter parts, presence of air bubbles during venous return, passage of the product between these 2 zones.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12132559
MDR Text Key261770099
Report Number1710034-2021-00553
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,Followup
Report Date 07/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381923
Device Lot Number0279633
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2020
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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