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U.S. Department of Health and Human Services

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

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VYGON GMBH NUTRLNE TWNFLO; LONG-TERM INTRAVASCULAR CATHETER Back to Search Results
Model Number 1252.230
Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)
Patient Problem Cardiac Tamponade (2226)
Event Date 01/03/2018
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
The patient did a tamponade after introduction of the catheter.It was placed a little bit too far, but the reaction of the child was very intense.
 
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Brand Name
NUTRLNE TWNFLO
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 Key7450447
MDR Text Key106155319
Report Number2245270-2018-00016
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
PMA/PMN Number
K052475
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 04/18/2018
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 Number1252.230
Device Lot NumberUNKNOWN
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/14/2018
Initial Date FDA Received04/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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