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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER Back to Search Results
Catalog Number 382523
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Infiltration into Tissue (1931); Ulcer (2274); No Code Available (3191)
Event Date 12/13/2018
Event Type  Injury  
Manufacturer Narrative
Device expiration date: unknown. Bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Root cause is undetermined. No sample, lot, or batch provided. Device manufacture date: unknown.
 
Event Description
It was reported that the 22g x 1. 00in (0. 9 x 25 mm) insyte autoguard bc caused an infection ultimately resulting in amputation with the customer saying ¿it was reported that three days after placement it was found that the catheter had infiltrated and a wound had formed. The patient contracted an infection of the right foot and right leg and had a large ulcer on the dorsal right foot. After consultation with doctors, the patient elected to proceed with right, below-knee amputation. ¿.
 
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Brand Name22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD BC
Type of DeviceINTERVASCULAR 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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8383961
MDR Text Key137659719
Report Number1710034-2019-00232
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number382523
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/01/2019 Patient Sequence Number: 1
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