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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

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VYGON UMBILICAL CATHETER Back to Search Results
Model Number 1272.14
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/23/2019
Event Type  Injury  
Manufacturer Narrative
The failed sample will be returned to vygon for device 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. The batch review shows that it is compliant to its specification. No deviation is registered. There is no complaint reported on this batch.
 
Event Description
A preterm infant had a uvc in situ (6cm at stump) in order to receive tpn. As she was tolerating full enteral feeds, the uvc was clamped at approximately 02:00 by myself in preparation for removal. I requested for the annp to come and remove it at approximately 03:30. As the procedure was being performed, the catheter snapped at 5cm. The annp had commented that it was difficult and had soaked the stump with chlorohexidine and a gauze swab. Deterioration of patient. Patient transferred to tertiary centre for ongoing treatment. The neonatal registrar was contacted immediately who came to review the patient. An abdominal and chest x-ray was performed. The consultant on call was contacted by the registrar and a plan was initiated to transfer the infant to the local tertiary centre for the remaining part of the catheter to be surgically removed. Surgical removal of the remainder of the line. The unit have advised that the baby is back and doing well following a laparotomy to remove the remainder of the line.
 
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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, PA 19446
8004735414
MDR Report Key9097378
MDR Text Key163823520
Report Number2245270-2019-00059
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
PMA/PMN Number
K981630
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1272.14
Device Catalogue Number1272.14
Device Lot Number080219EJ
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2019
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: 09/20/2019 Patient Sequence Number: 1
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