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Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2022 |
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.The device was not returned.
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Event Description
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It was reported that the foley catheter tube was twisted while placed in the statlock.Representative discussed about positioning according to arrow pointed towards catheter tip and lumen placement within statlock.Statlock should not cause foley to twist if placed correctly.Customer stated that they do not manage patient's foley or statlock but by the home nurse.Representative had sent foley faq's, ifu, poster and carp tips to optimize performance.Also suggested providing to home health nurse and dault daycare.Noted nurse needed to evaluate foley since it is clamping off and urine was not draining.
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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 "user does not follow labeling instructions".The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore, bd was unable to determine the associated labeling to review.H11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the device was not returned.
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Event Description
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It was reported that the foley catheter tube was twisted while placed in the statlock.Representative discussed about positioning according to arrow pointed towards catheter tip and lumen placement within statlock.Statlock should not cause foley to twist if placed correctly.Customer stated that they do not manage patient's foley or statlock but by the home nurse.Representative had sent foley faq's, ifu, poster and carp tips to optimize performance.Also suggested providing to home health nurse and dault daycare.Noted nurse needed to evaluate foley since it is clamping off and urine was not draining.
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Search Alerts/Recalls
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