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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER

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BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER Back to Search Results
Model Number 382523
Device Problem Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: bd received no sample and one photo. Inspection of the photo revealed the catheter adapter assembly was intact over the needle with the tip of the needle piercing through the catheter tubing wall. The defect of needle through catheter was confirmed. There was no media visible; however, it was noted in the event description that the unit had been used in venipuncture. No other anomalies or damage could be observed to the unit or components due to the limited view in the photo. Since the unit had been used, it is unlikely that the defect occurred during manufacturing as the device would have been received with the needle piercing through the catheter tubing, making a venipuncture attempt unlikely. A needle spear through may occur in the user setting during tip adhesion break, during venipuncture if the needle is advanced at a wrong angle, or if the needle is moved up and down the catheter tubing. A device history record review showed no non-conformance's 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 bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology had a sheared catheter. The following information was provided by the initial reporter: "iv was inserted into patient, rn did not see any blood return, rn attempted to maneuver iv to get blood return, but expressed that the iv felt "weird" in the patient, so she removed the entire device. Upon removing device, she noticed that the catheter was sheared".
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12682203
MDR Text Key278360056
Report Number1710034-2021-00909
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 10/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number382523
Device Catalogue Number382523
Device Lot Number1182812
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2021
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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