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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Urinary Tract Infection (2120); Hematuria (2558)
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Event Date 03/16/2022 |
Event Type
Injury
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Event Description
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It was reported that the customer mentioned bacteriuria, symptomatic urinary tract infection, pain, hematuria, urethral or bladder trauma, catheter blockage and leakage when asked about the complications while using the foley catheter.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention was unknown.
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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 customer mentioned bacteriuria, symptomatic urinary tract infection, pain, hematuria, urethral or bladder trauma, catheter blockage and leakage when asked about the complications while using the foley catheter.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention was unknown.
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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 ¿tortuous anatomy".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: "to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.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, preventing balloon deflation.If necessary, contact.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 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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Search Alerts/Recalls
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