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Model Number 802110 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bardia foley catheter insertion tray was empty, only had the packaging material and no medical products.
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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.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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Event Description
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It was reported that the bardia foley catheter insertion tray was empty, only had the packaging material and no medical products.
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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 specifications.The product does not appear to have been used.However, the product is intended to be used for treatment purpose but it was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "machine speed out of parameters".The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labelling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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Search Alerts/Recalls
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