Model Number 119108 |
Device Problems
Partial Blockage (1065); Inaccurate Flow Rate (1249)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that after temperature sensing catheter insertion, urine did not flow.The open as normal and inserted by hand.The use was discontinued.Per follow up information received on 18oct2021, blockage in the catheter was unknown.
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Manufacturer Narrative
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The reported event was confirmed as manufacturing-related.One sample exhibited the reported failure.The device had not met specifications.The product was used for patient treatment or diagnosis.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley.Visual inspection of the sample noted no obvious visible defects.The drainage lumen was flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water) and the solution was unable to pass by the drainage funnel.The drainage funnel was noted to have a silicone blockage at the narrowest section.This does not meet the specification "check for defects: excessive material (over fill), bubbles/voids, splits and/or blemishes." a potential root cause for this failure could be "tooling wear".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labelling could not have prevented the reported failure.The actual/suspected device was inspected.
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Event Description
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It was reported that after temperature sensing catheter insertion, urine did not flow.The open as normal and inserted by hand.The use was discontinued.Per follow up information received on 18oct2021, blockage in the catheter was unknown.
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Search Alerts/Recalls
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