Model Number 270.04 |
Device Problems
Break (1069); Material Fragmentation (1261)
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Patient Problems
Device Embedded In Tissue or Plaque (3165); No Information (3190)
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Event Date 02/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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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.No non-conformities of the batch history records detected.The products are in conformity with the specifications.The device is compliant to iso norm 10555-1.The tensile strength is higher than 10n which is the norm minimum value.There is no other complaint on this batch.
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Event Description
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An umbilical catheter was introduced.Then x-ray was done.The catheter was broken during correction of the position of this catheter.Urgent consultation of a pediatric specialist.Removal of the entire fragment of the umbilical catheter.The patient feels good, his condition is stable.
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Manufacturer Narrative
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We have received the involved umbilical catheter.The visual examination of the involved umbilical catheter shows that it is broken between the centimetrics mark 9 and 10 cm.On the fractured surface we noticed an even area and v part.This is characteristic of a damaged tube by the cut of a sharp object , on which a mechanical force has been applied.The damage caused probably by a forceps has significantly weakened the catheter, resulting in a complete fracture on the application of a tensile (pulling) force during the correction of the catheter's position.The tensile strength results during manufacturing are all above the iso norm value of 10n.The minimum measured value is 16,7n.The historical data analysis , shows that there is no other complaint on this batch.This event is not linked to a quality defect of this device but its conditions of use.In the instruction of use, we recommend to use non-toothed forceps.
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Event Description
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An umbilical catheter was introduced.Then x-ray was done.The catheter was broken during correction of the position of this catheter.Urgent consultation of a pediatric specialist.Removal of the entire fragment of the umbilical catheter.The patient feels good, his condition is stable.
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Search Alerts/Recalls
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