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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; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381044
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 11/22/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter city: (b)(6).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¿ bc shielded iv catheter was involved with a patient experiencing infection without a reported device defect/malfunction.There was no report of medical intervention.The following information was provided by the initial reporter: device implicated in the lymphangitis that occurred recently.No medical intervention was needed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/16/2021.H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one unit which was inspected for any defects that could cause an infection or irritation to the patient.A microscopic inspection of the catheter tip was performed and found to be within specification.The catheter tubing was also inspected for any defects and no abnormalities or defects were found.Finally sterilization and lubrication records were reviewed and no quality issues or process deviations were found.Irritation or infection may also be affected by the sterility of the product in regard to package integrity and site sterility.Without the package for investigation, the package integrity could not be inspected.Additionally, site sterility cannot be determined without being present during venipuncture.As the returned unit was found to be within specifications, bd was unable to confirm the reported defect.A device history record review showed no non-conformance's associated with this issue during the production of this batch.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter was involved with a patient experiencing infection without a reported device defect/malfunction.There was no report of medical intervention.The following information was provided by the initial reporter: device implicated in the lymphangitis that occurred recently.No medical intervention was needed.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR 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 Key13047975
MDR Text Key286743364
Report Number1710034-2021-01069
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 02/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date03/31/2024
Device Catalogue Number381044
Device Lot Number1095350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/05/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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