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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY INSYTE AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BECTON, DICKINSON AND COMPANY INSYTE AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 381434
Device Problems Break (1069); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 06/07/2019
Event Type  Injury  
Event Description
The rn started a 20g iv in patient's rt ac.She looked at the catheter before inserting and everything was in place.She started the iv and received flashback.She tried to advance it and felt resistance, repositioned and it went in.She then flushed it and it didn't flush.She d/c'd the iv and pulled out the cath.She noticed a piece broke off of the plastic catheter in the patient's vessel.We reversed his anticoagulation and transferred the patient to another hospital with plan to remove the catheter from the vessel in surgery.
 
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Brand Name
INSYTE AUTOGUARD
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton dr
franklin lakes NJ 07417
MDR Report Key8940013
MDR Text Key155843564
Report Number8940013
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number381434
Device Catalogue Number381434
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/12/2019
Event Location Hospital
Date Report to Manufacturer08/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age20075 DA
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