Device Problem
Inaccurate Flow Rate (1249)
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Patient Problem
Urinary Retention (2119)
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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.
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Event Description
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It was reported that the foley temperature sensing 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 renal 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 drained.This also happened last 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.
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Event Description
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It was reported that the foley temperature sensing 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 renal 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 drained.This also happened last night for retention issues with bard foley catheter.No medical intervention was reported.
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Event Description
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It was reported that the foley temperature sensing 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 renal 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 drained.This also happened last 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 ¿inadequate material selection".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.The device was not returned.
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Search Alerts/Recalls
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