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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RF400F

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BARD PERIPHERAL VASCULAR, INC. RF400F Back to Search Results
Catalog Number RF400F
Device Problem Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2015
Event Type  Injury  
Event Description
It was reported that during a vena cava filter deployment procedure, the filter remained inside the sheath and could not be deployed.A new access site was gained as another filter was prepped and deployed successfully.There was no reported patient injury.
 
Manufacturer Narrative
The lot number has been provided and the device history records are being reviewed.The investigation is currently underway.
 
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Brand Name
RF400F
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
tempe AZ
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804 204
Manufacturer Contact
bryan vogel
1625 west 3rd st
tempe, AZ 85281
4808949515
MDR Report Key4538139
MDR Text Key5354057
Report Number2020394-2015-00066
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K080668
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2016
Device Catalogue NumberRF400F
Device Lot NumberGFXE3339
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/22/2015
Initial Date FDA Received02/17/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age54 YR
Patient Weight62
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