Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Erosion (1750); Tissue Breakdown (2681)
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Event Date 12/06/2022 |
Event Type
Injury
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Event Description
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It was reported that 20 separate datix incident reports of urethral injury from bard foley catheters had been received.The injuries range from unclassified to 1.5 cm erosion.It was stated that this patient had uncategorized urethral damage only.The number of patients involved were 20.It was stated that the tissue viability team were contacted and all patients were treated appropriately for their injury.
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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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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 "materials of construction are not biocompatible".It is unknown whether the device had met relevant specifications.The product was used for 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 instructions for use were found adequate and state the following: "warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single use only.Do not reuse.Do not resterilize.For urological use only.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.¿ 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 20 separate datix incident reports of urethral injury from bard foley catheters had been received.The injuries range from unclassified to 1.5 cm erosion.It was stated that this patient had uncategorized urethral damage only.The number of patients involved were 20.It was stated that the tissue viability team were contacted and all patients were treated appropriately for their injury.
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Search Alerts/Recalls
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