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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. MICRO-INTRODUCER KIT; INTRODUCER, CATHETER
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VASCULAR SOLUTIONS, INC. MICRO-INTRODUCER KIT; INTRODUCER, CATHETER Back to Search Results
Model Number 7208V
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/19/2014
Event Type  malfunction  
Event Description
Physician reported that the needle in the micro-introducer kit did not feel as they as sharp as previous needles.No pt impact was reported.During product investigation a burr was discovered on the distal tip of the needle.
 
Manufacturer Narrative
The reported event relates to the needle component of a vascular solutions' kit, but the needle component is not manufactured by vascular solutions.The complaint has been forwarded to the supplier.
 
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Brand Name
MICRO-INTRODUCER KIT
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
minneapolis MN 55369
Manufacturer (Section G)
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
minneapolis MN 55369
Manufacturer Contact
beka vite
6464 sycamore court north
minneapolis, MN 55369
7636575732
MDR Report Key3941021
MDR Text Key4572069
Report Number2134812-2014-00021
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101604
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2017
Device Model Number7208V
Device Lot Number571710
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/22/2014
Initial Date Manufacturer Received 05/19/2014
Initial Date FDA Received06/19/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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