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Model Number 165816 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Urinary Tract Infection (2120); Hematuria (2558)
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Event Date 03/03/2022 |
Event Type
Injury
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Event Description
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It was reported that the customer mentioned about symptomatic urinary tract infection, pain, hematuria, epididymitis, urethral trauma, catheter blockage, leakage and accidental removal when they were asked about the complications while using the foley catheter.It was unknown what medical intervention was provided.
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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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Manufacturer Narrative
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The reported event was inconclusive as no sample is available.A potential root cause for this failure could be due to " materials of construction are not biocompatible".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: "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.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
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Event Description
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It was reported that the customer mentioned about symptomatic urinary tract infection, pain, hematuria, epididymitis, urethral trauma, catheter blockage, leakage and accidental removal when they were asked about the complications while using the foley catheter.It was unknown what medical intervention was provided.
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Search Alerts/Recalls
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