Catalog Number 171305-000120 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Information (3190)
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Event Date 02/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that for a (b)(6)-year-old patient, (b)(6) kg.There was leakage of the catheter.Happened with 4 patients.The product manager stated that it is not an incident due to the devices but an incident due to the age of the patients.Information was provided on (b)(6) 2020 to customer to inform about issues that can occur with old patients (bladder neck distends).The leakage would be due to an anatomic reason where the seal cannot be performed the same way for very old patients and younger patients.The opinion of the product managers was just provided as a simple opinion that would have may helped for the investigation.
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Event Description
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It was reported that for a 96-year-old patient, 72.8 kg.There was leakage of the catheter.Happened with 4 patients.The product manager stated that it is not an incident due to the devices but an incident due to the age of the patients.Information was provided on 20 january 2020 to customer to inform about issues that can occur with old patients (bladder neck distends).The leakage would be due to an anatomic reason where the seal cannot be performed the same way for very old patients and younger patients.The opinion of the product managers was just provided as a simple opinion that would have may helped for the investigation.
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Manufacturer Narrative
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(b)(4).The device lot number was not provided; therefore, a dhr review could not be conducted.Due to limited information and no sample returned available for investigation, it is difficult to determine the real root cause of the failure whether it is due to product malfunction or an incident related to patient.In the absence of the returned sample and limited information available on this complaint, further investigation to determine actual root cause of the problem reported could not be determined.Therefore, this complaint could not be confirmed.
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Search Alerts/Recalls
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