Device Problem
Inaccurate Flow Rate (1249)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be user related (example: salt accumulation)/block drainage lumen/no drainage eye.) unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.
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Event Description
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It was reported that the foley catheters were vapor locked and so the urine did not drain properly.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be user related (example: salt accumulation)/block drainage lumen/no drainage eye.) unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.
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Event Description
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It was reported that the foley catheters were vapor locked and so the urine did not drain properly.
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Search Alerts/Recalls
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