Device Problem
Inaccurate Flow Rate (1249)
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Patient Problems
Urinary Retention (2119); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/02/2022 |
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 temperature sensing foley catheters were not draining appropriately and resulted in significant retention in two patients.Customer stated that they were diligent about positioning the catheter to avoid kinks or occlusions.One patient had statlock in place, but the other did not have it.Customer mentioned that it was not just a little retention.One of the patients was consulted with renal department for an elevated creatinine.There were no obvious defects found when the catheter was exchanged and the catheter itself looked patent.The second patient had some significant chugging or elevated venous drainage pressures (ecmo) related to bladder distention.It was further reported that few other nurses have faced similar issues where they had to exchange the foley catheter and 2 liters of urine was drained.This also happened the previous night for retention issues with bard foley catheter.No medical intervention was reported.
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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 temperature sensing foley catheters were not draining appropriately and resulted in significant retention in two patients.Customer stated that they were diligent about positioning the catheter to avoid kinks or occlusions.One patient had statlock in place, but the other did not have it.Customer mentioned that it was not just a little retention.One of the patients was consulted with renal department for an elevated creatinine.There were no obvious defects found when the catheter was exchanged and the catheter itself looked patent.The second patient had some significant chugging or elevated venous drainage pressures (ecmo) related to bladder distention.It was further reported that few other nurses have faced similar issues where they had to exchange the foley catheter and 2 liters of urine was drained.This also happened the previous night for retention issues with bard foley catheter.No medical intervention was reported.
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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 ¿biological deposits¿.It was unknown whether the device had met relevant specifications.The product was used for diagnostics and treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device was unknown.Therefore, bd is 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.
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Event Description
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It was reported that the temperature sensing foley catheters were not draining appropriately and resulted in significant retention in two patients.Customer stated that they were diligent about positioning the catheter to avoid kinks or occlusions.One patient had statlock in place, but the other did not have it.Customer mentioned that it was not just a little retention.One of the patients was consulted with renal department for an elevated creatinine.There were no obvious defects found when the catheter was exchanged and the catheter itself looked patent.The second patient had some significant chugging or elevated venous drainage pressures (ecmo) related to bladder distention.It was further reported that few other nurses have faced similar issues where they had to exchange the foley catheter and 2 liters of urine was drained.This also happened the previous night for retention issues with bard foley catheter.No medical intervention was reported.
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Search Alerts/Recalls
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