Device Problems
Fitting Problem (2183); No Flow (2991)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/27/2018 |
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 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.The device was not returned.
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Event Description
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It was reported that (b)(6) was an in-patient at (b)(6) since (b)(6) this year.Her catheter was changed four times this month, because it stopped functioning.Urine stopped flowing into the bag.A braun twin insertion flushing device was used to flush the tube.The patient allegedly does not have kidney stones.A prosys urine bag was fitted into the statlock, however the clip would not shut properly.
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Event Description
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It was reported that (b)(6) was an in-patient at (b)(6), since (b)(6) this year.Her catheter was changed four times this month, because it stopped functioning.Urine stopped flowing into the bag.A braun twin insertion flushing device was used to flush the tube.The patient allegedly does not have kidney stones.A prosys urine bag was fitted into the statlock, however the clip would not shut properly.
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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.The product family for this statlock product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the statlock product ifus are found to be adequate based on past reviews.
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Search Alerts/Recalls
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