Catalog Number 910121 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A facility reported that the lumbar catheter (910121) ruptured at the connection site to the supplied connector on little pull while the staff repositioned the patient.Extensive disinfection and some shortening of the catheter under sterile conditions and new application of a connector from a new set was performed.It is unknown if the event led to increased surgery time; however, there was no injury to the patient.
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Manufacturer Narrative
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An evaluation of the lumbar catheter (910121) could not be performed because the facility lost the device.However, lot number was provided; therefore, device history records were reviewed which revealed no anomalies that could explain the reported event.Without actual device to investigate, complaint is unverifiable and the exact root cause of the reported event could not be determined.No further investigation nor corrective action is deemed required.
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Search Alerts/Recalls
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