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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON GMBH PREMICATH; LONG-TERM INTRAVASCULAR CATHETER

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VYGON GMBH PREMICATH; LONG-TERM INTRAVASCULAR CATHETER Back to Search Results
Model Number 1261.20
Device Problems Malposition of Device (2616); Positioning Problem (3009)
Patient Problem Pleural Effusion (2010)
Event Date 03/27/2018
Event Type  Injury  
Manufacturer Narrative
The device involved in this event will be returned to vggon for evaluation as part of the complaint investigation.The results of this investigation are still pending and will be communicated to fda within 30 days of its conclusion via follow-up mdr.
 
Event Description
Deteriotion of respiration and hemodynamics, suspicion of malplaced catheter.Therefore, the idea of pleural drainage was born.
 
Manufacturer Narrative
It was not possible to flush the catheter because of several occlusions.A thoroughly microscopic step by step examination showed a lot of fibrins adhering to the catheter tube but no defect could be detected which might have led to a leakage.This is the second complaint for batch 040817gj (co-2018-0307 - same customer), the 35th complaint for a leaking catheter tube on code 1261.20 and the 5th regarding inflammation or phlebitis with code 1261.210 within the last 3 years but none of these complaints manufacturing related.This is the first complaint on code 1261.20 regarding oedema within the last 4 years.
 
Event Description
Deteriotion of respiration and hemodynamics, suspicion of malplaced catheter.Therefore, the idea of pleural drainage was born.
 
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Brand Name
PREMICATH
Type of Device
LONG-TERM INTRAVASCULAR CATHETER
Manufacturer (Section D)
VYGON GMBH
prager ring 100
aachen, 52070
GM  52070
Manufacturer (Section G)
VYGON GMBH
prager ring 100
aachen, 52070
GM   52070
Manufacturer Contact
freda lacroix
2750 morris road
lansdale, PA 19446
8004735414
MDR Report Key7450421
MDR Text Key106155263
Report Number2245270-2018-00015
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
PMA/PMN Number
K954302
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/26/2018
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? No
Device Operator No Information
Device Model Number1261.20
Device Lot Number040817GJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/03/2018
Initial Date FDA Received04/23/2018
Supplement Dates Manufacturer Received04/03/2018
Supplement Dates FDA Received04/27/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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