Model Number N/A |
Device Problems
Decrease in Pressure (1490); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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This device is reported to be available for analysis but has not been received at the time of this report.Additional information is pending and will be submitted within 30 days upon receipt.
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Event Description
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As reported, a 5f mynxgrip vascular closure device (vcd) kept air getting into the system somewhere and the balloon wasn¿t inflating properly and therefore, wasn't prepping correctly.A new one was pulled from the same box and it worked fine.There was no harm to the patient and no reported patient injury.The device was never inserted.The device is available for evaluation.
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Manufacturer Narrative
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This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
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Search Alerts/Recalls
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