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Catalog Number 123516A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Urinary Tract Infection (2120)
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Event Date 12/11/2023 |
Event Type
Injury
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.Potential root cause for this failure mode could not be chosen due to insufficient information.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "sterile unless package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon burst.Do not aspirate urine through the drainage funnel wall.Single patient use only.Do not reuse and resterilize.For urological use only.Use luer slip syringe.Do not use needle.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen.If permitted by hospital protocol, they may be cut off.If this fails, contact an adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." 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 the foley catheter caused a severe urinary tract infection and 5-day hospital stay.It was unknown what medical intervention was provided for the urinary tract infection at this time.
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Event Description
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It was reported that the foley catheter caused a severe urinary tract infection and 5-day hospital stay.It was unknown what medical intervention was provided for the urinary tract infection at this time.Per additional information received on 16jan2024, it was stated that the customer had a urinary infection and allergic reaction.The catheter was made in mexico.Catheter was changed out every 3-4 weeks and complications were very strong and infected.Patient did suffer from latex allergy.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.Potential root cause for this failure mode could not be chosen due to insufficient information.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "sterile unless package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon burst.Do not aspirate urine through the drainage funnel wall.Single patient use only.Do not reuse and resterilize.For urological use only.Use luer slip syringe.Do not use needle.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen.If permitted by hospital protocol, the may be cut off.If this fails, contact an adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." 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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Search Alerts/Recalls
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