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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INSYTE AUTOGARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BD INSYTE AUTOGARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 381523
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2017
Event Type  malfunction  
Event Description
Iv would not accept the secure tubing for injection. On examining catheter it was found to have excess plastic around the hub left from the manufacturing process. The iv was removed and another inserted for the patient's procedure.
 
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Brand NameINSYTE AUTOGARD
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BD
5859 farinon dr.
ste. 200
san antonio TX 78249
MDR Report Key6629700
MDR Text Key77201748
Report Number6629700
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 06/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2017
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model Number381523
Device Lot Number7047617
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/01/2017
Device Age1 DY
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer06/01/2017
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

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