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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 381433
Device Problems Break (1069); Device Dislodged or Dislocated (2923)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/22/2017
Event Type  Injury  
Event Description
Event was not witnessed by staff and details are provided by patient's statement: patient was lying in bed with arm hanging off side of bed. A visitor came to the door of the patient's room and when the patient turned over in bed, the angiocath became caught on something (unknown) and was pulled out of the patient's right antecubital space. Angiocath had been saline locked and was not connected to any fluids/medications at the time of the event. The angiocath had been secured in a standard fashion using the adhesives provided with iv start kit. A portion of the angiocath appeared to be broken off and retained in the patient. The patient was evaluated and sent to vascular surgery where ~1. 8cm of the angiocath was retrieved from the patient's subcutaneous tissue.
 
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Brand NameBD INSYTE AUTOGUARD
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
9450 south state street
sandy UT 84070
MDR Report Key6739868
MDR Text Key80899322
Report Number6739868
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number381433
Device Catalogue Number381433
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/17/2017
Event Location Hospital
Date Report to Manufacturer07/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/25/2017 Patient Sequence Number: 1
Treatment
NO OTHER THERAPIES
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