Catalog Number 80219 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a recanalization procedure, the blood foam was found at the rear end of the collection chamber of the handle.It was further reported that a leak was allegedly found at the rear end of the collection compartment of the handle and it could not be used normally.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex that are cleared in the us.The pro code and 510 k number for the rotarex are identified in d2 and g4.H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provide by bd represents all 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 bd.H3 other text : device not returned.
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex that are cleared in the us.The pro code and 510 k number for the rotarex are identified in d2 and g4.H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical sample was not returned for evaluation, thus the physical investigation was not possible.The user report contains information regarding leakage of catheter handle.The image provided by the user do not show leakage and do not bring sufficient information.This malfunction could be result of possible mechanical jam, strong kink near the handle or damage of the tube.Due to no physical sample available it is not possible to clearly identify the cause of the leak.Therefore, the result of the investigation is inconclusive for the reported leak/splash issue.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all 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 bd.
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Event Description
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It was reported that during a recanalization procedure, the blood foam was found at the rear end of the collection chamber of the handle.It was further reported that a leak was allegedly found at the rear end of the collection compartment of the handle and it could not be used normally.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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