Device Problem
Torn Material (3024)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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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 statlock device created a tear in the foley catheter, near the bifurcation.
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Manufacturer Narrative
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The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the latex catheter product ifus are found to be adequate based on past reviews.(b)(4).
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Event Description
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It was reported that the statlock device created a tear in the foley catheter, near the bifurcation.
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Search Alerts/Recalls
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