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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381023
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
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 when using the bd insyte¿ autoguard¿ bc shielded iv catheter the needle would not retract.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "after placing iagbc for a patient, the hcp pressed the button to activate the safety mechanism but the needle was not retracted.The safety barrel was then removed from the catheter hub with the needle exposed.Catheter placement itself was completed.".
 
Event Description
It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter the needle would not retract.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "after placing iagbc for a patient, the hcp pressed the button to activate the safety mechanism but the needle was not retracted.The safety barrel was then removed from the catheter hub with the needle exposed.Catheter placement itself was completed.".
 
Manufacturer Narrative
H6: investigation summary three photos and two used samples were received by our quality team for evaluation.Visual inspection of the returned samples and provided photos found that the needle was not retracted in either unit and the button was depressed in one of the units.Further inspection was performed using a microscope.This inspection found that adhesive was present on both units in between the needle hub and the grip.Functional testing also verified that either button could not be pressed, and the needle could not be retracted, confirming the customer experience.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.This type of defect may occur when adhesive is unintentionally applied to the outside of the hub, where the adhesive may then seep down into the other components.This may occur at the adhesive dispense process due to station misalignment, part misalignment, or adhesive buildup on the nozzle.Per the quality control plan, inspection for needle retraction and excessive adhesive are performed periodically during the manufacturing process to mitigate the occurrence of this defect.Preventative maintenance is performed to maintain and ensure proper functioning of equipment.The preventative maintenance records were verified to be up to date during the production of this lot.A notification of this complaint was sent to the manufacturing department to raise awareness of this nonconformance.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
MDR Report Key12411671
MDR Text Key270312878
Report Number1710034-2021-00775
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 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2023
Device Catalogue Number381023
Device Lot Number0335177
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2021
Initial Date Manufacturer Received 08/04/2021
Initial Date FDA Received09/01/2021
Supplement Dates Manufacturer Received09/09/2021
Supplement Dates FDA Received09/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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