• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER UMBILICAL CATHETER,

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VYGON UMBILICAL CATHETER UMBILICAL CATHETER, Back to Search Results
Catalog Number 1272.14
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/16/2018
Event Type  Injury  
Manufacturer Narrative
The malfunctioning device will be returned to vygon for evaluation as part of the complaint investigation. We have checked the history of complaints on both batches these devices, no similar event is registered. The batches review does not shown any deviation or non-conformity. The tensile strength is compliant to (b)(4).
 
Event Description
The umbilical catheter was inserted on (b)(6) 2017. The x-ray controls were correct. The (b)(6), the physician ordered to remove the catheter. It snapped and 5 cm left inside the patient. It was removed by incision theater. No patient outcome has been reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUMBILICAL CATHETER
Type of DeviceUMBILICAL CATHETER,
Manufacturer (Section D)
VYGON
5 rue adeline
ecouen, 95440
FR 95440
Manufacturer (Section G)
VYGON
5 rue adeline
ecouen, 95440
FR 95440
Manufacturer Contact
freda lacroix
2750 morris road
lansdale, PA 19446
8004735414
MDR Report Key7276621
MDR Text Key100263442
Report Number2245270-2018-00005
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
PMA/PMN Number
K921352
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1272.14
Device Lot Number150317EJ OR 100117EJ
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/18/2018
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 Treatment Data
Date Received: 02/16/2018 Patient Sequence Number: 1
-
-