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Device Problem
Component Misassembled (4004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2023 |
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.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 while conducting insertion observations, a nurse opened a surestep foley tray to find two lubricant syringes inside, but no sterile water syringe.Per follow up via email on 24jul2023, it was stated that the product was not in use on a patient so no intervention was required.The product was unexpired and being used for nursing education.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "human error ".The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labeling 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.
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Event Description
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It was reported that while conducting insertion observations, a nurse opened a surestep foley tray to find two lubricant syringes inside, but no sterile water syringe.Per follow up via email on 24jul2023, it was stated that the product was not in use on a patient so no intervention was required.The product was unexpired and being used for nursing education.
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Search Alerts/Recalls
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