• 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

  • 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 Back to Search Results
Model Number 1270.03
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/25/2020
Event Type  Injury  
Manufacturer Narrative
The malfunctioning device will be returned to vygon for evaluation and investigation. The results of this investigation will be sent to fda in a follow-up mdr with in thirty days of its conclusion. The batch review does not shown any non-conformity. The device complies with iso 10555-1 standard. The tensile strength is higher than 10 newton which is the average minimum value. There are no other complaints in this batch.
 
Event Description
The serious adverse event occured the (b)(6) 2020. The umbilical catheter was inserted in a premature patient on (b)(6) 2020. No problem has been observed during the use period of 16 days. Tpn and other drugs were infused. During the removal of the catheter from the patient, the catheter was broken and some of it remained in the patient's body. The broken part was removed by surgical intervention.
 
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 o lacroix
2750 morris road
lansdale, PA 19446
8004735414
MDR Report Key10676817
MDR Text Key211243279
Report Number2245270-2020-00105
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
PMA/PMN Number
K921374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1270.03
Device Catalogue Number1270.03
Device Lot Number260819PA
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2020
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: 10/14/2020 Patient Sequence Number: 1
-
-