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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD INSYTE AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BECTON, DICKINSON AND COMPANY BD INSYTE AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 382523
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cellulitis (1768); Unspecified Infection (1930); Infiltration into Tissue (1931); Necrosis (1971); Ulcer (2274)
Event Date 12/10/2018
Event Type  Injury  
Event Description
An iv was placed in the patient's right foot due to poor access in the upper extremities.Three days later it was discovered that it had infiltrated.It was removed and wound saw the patient, cleansing and bandaging the area.The patient was discharged to a skilled nursing facility.Two weeks later, the patient presented to outpatient wound care and was then sent to the ed for further evaluation of the right foot and was found to have right foot cellulitis with a necrotic wound.The patient was admitted for further treatment including iv antibiotics.Discussions were held regarding the possible need for surgical debridement versus amputation.Further evaluation determined that the patient was not a candidate for debridement and a right, below the knee amputation was performed early this year.From op report: patient has had an infection of the right foot and right leg.Patient has a large ulcer on the dorsal right foot the anterior aspect of the right ankle.Orthopedics was initially consulted for management.We felt that with the patient's ambulatory status, and overall status that the most definitive management would be a below-knee amputation.Patient is not an ambulator.The patient also was seen by plastic surgery.They did not feel that the ulcer was reconstructible with any soft tissue procedures.Since this has been a source of infection they agreed that an amputation would be the reasonable.The patient and the patient's family have considered this and elected to proceed with the right below-knee amputation.
 
Event Description
An iv was placed in the patient's right foot due to poor access in the upper extremities.Three days later it was discovered that it had infiltrated.It was removed and wound saw the patient, cleansing and bandaging the area.The patient was discharged to a skilled nursing facility.Two weeks later, the patient presented to outpatient wound care and was then sent to the ed for further evaluation of the right foot and was found to have right foot cellulitis with a necrotic wound.The patient was admitted for further treatment including iv antibiotics.Discussions were held regarding the possible need for surgical debridement versus amputation.Further evaluation determined that the patient was not a candidate for debridement and a right, below the knee amputation was performed early this year.From op report: patient has had an infection of the right foot and right leg.Patient has a large ulcer on the dorsal right foot the anterior aspect of the right ankle.Orthopedics was initially consulted for management.We felt that with the patient's ambulatory status, and overall status that the most definitive management would be a below-knee amputation.Patient is not an ambulator.The patient also was seen by plastic surgery.They did not feel that the ulcer was reconstructible with any soft tissue procedures.Since this has been a source of infection they agreed that an amputation would be the reasonable.The patient and the patient's family have considered this and elected to proceed with the right below-knee amputation.
 
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Brand Name
BD INSYTE AUTOGUARD
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
one becton drive
franklin lakes NJ 07417
MDR Report Key8309783
MDR Text Key135157597
Report Number8309783
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number382523
Device Catalogue Number382523
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/25/2019
Event Location Hospital
Date Report to Manufacturer02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Congenital Anomaly; Hospitalization; Life Threatening; Required Intervention; Disability;
Patient Age25915 DA
Patient Weight77
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