Model Number 123516A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/13/2020 |
Event Type
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.The device was not returned.
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Event Description
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It was reported that the foley catheter was moving up and down since the patient did not have any foley stabilization device which resulted in bacterial infection inside the patient's urethra.Patient stated that it had caused two urinary tract infections and also experienced bleeding.It was unknown what medical intervention was provided for the urinary tract infection and bleeding.
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Manufacturer Narrative
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The reported event was inconclusive.No sample was returned for evaluation.However, the potential root cause for this failure mode could be due to short drainage funnel, slanted funnel, improper handling by user.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: "single use only.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle." the device was not returned.
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Event Description
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It was reported that the foley catheter was moving up and down since the patient did not have any foley stabilization device which resulted in bacterial infection inside the patient's urethra.Patient stated that it had caused two urinary tract infections and also experienced bleeding.It was unknown what medical intervention was provided for the urinary tract infection and bleeding.
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Search Alerts/Recalls
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