Device Problems
Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Hemorrhage/Bleeding (1888)
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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 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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Event Description
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It was reported that during insertion of a 3-way catheter, the nurse was unable to advance the catheter.There were blood clots and pinkish urine returned in the catheter drainage tubing.The nurse felt the catheter was too large for the patient and the 3-way catheter was aborted.A regular indwelling catheter was placed.No additional medical interventions were reported.Clinical statement: the intended use for a 3-way catheter is used for drainage after bladder or upper urinary tract surgeries to add continuous irrigation capabilities.Continuous irrigation catheters help to remove tissue chips, blood clots and other debris form the bladder after surgery.(b)(6).
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Manufacturer Narrative
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The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product catalog number is unknown, the catheter product ifus are found to be adequate based on past reviews.Correction: concomitant medical products and device evaluated by mfr.
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Event Description
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It was reported that during insertion of a 3-way catheter, the nurse was unable to advance the catheter.There were blood clots and pinkish urine returned in the catheter drainage tubing.The nurse felt the catheter was too large for the patient and the 3-way catheter was aborted.A regular indwelling catheter was placed.No additional medical interventions were reported.Clinical statement: the intended use for a 3-way catheter is used for drainage after bladder or upper urinary tract surgeries to add continuous irrigation capabilities.Continuous irrigation catheters help to remove tissue chips, blood clots and other debris form the bladder after surgery.(b)(4) , rn.
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Search Alerts/Recalls
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