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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. LANGSTON DUAL LUMEN CATHETER
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VASCULAR SOLUTIONS, INC. LANGSTON DUAL LUMEN CATHETER Back to Search Results
Model Number 5515
Device Problems Air Leak (1008); Flushing Problem (1252)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2014
Event Type  malfunction  
Event Description
A langston dual lumen catheter was used during a patient procedure.The langston was removed from the patient due to difficulty flushing and then re-inserted.During the second flushing attempt, the physician observed bubbles near the hub.The physician believes there was no patient impact from the langston catheter.
 
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Brand Name
LANGSTON DUAL LUMEN CATHETER
Type of Device
CATHETER
Manufacturer (Section D)
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
maple grove MN 55369
Manufacturer (Section G)
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
maple grove MN 55369
Manufacturer Contact
renee runtsch
6464 sycamore court north
maple grove, MN 55369
7636564366
MDR Report Key3947031
MDR Text Key4537958
Report Number2134812-2014-00029
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061565
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date05/31/2016
Device Model Number5515
Device Lot Number573215
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received06/26/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2014
Is the Device Single Use? Yes
Patient Sequence Number1
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