Catalog Number 80223 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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.H10: d4 (expiration date: 03/2026).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.H3 other text : device not returned.
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Event Description
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It was reported that during a recanalization procedure, blood allegedly leaked from the connection tube and the green catheter housing.It was further reported that the connection tube to the collecting bag was not fixed to catheter housing and was allegedly found to be loose.There was no reported patient injury.
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Event Description
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It was reported that during a recanalization procedure, blood allegedly leaked from the connection tube and the green catheter housing.It was further reported that the connection tube to the collecting bag was not fixed to catheter housing and was allegedly found to be loose.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 products that are cleared in the us.The pro code and 510 k number for the rotarex products 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 sample was not returned for evaluation and a physical investigation was not possible.The user report contains information regarding leakage of catheter handle.The image provided by the user show that possible leak place was near collecting bag tube.This malfunction could be result of possible mechanical jam, strong kink near the handle or damage of the tube.The leak near the collecting bag tube can be result of bad collecting bag mounting or strong pull and tube being loosed from the catheter handle.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 issue.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 03/2026).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.H3 other text : device not returned.
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Search Alerts/Recalls
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