Catalog Number 80202 |
Device Problems
Break (1069); Flushing Problem (1252); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2023 |
Event Type
malfunction
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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: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, videos were provided for review.The investigation of the reported event is currently underway.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 pending return.
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Event Description
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It was reported that during a recanalization procedure, the tip end of the catheter was allegedly separated from the tube section.It was further reported that the device allegedly cannot be flushed upon removal.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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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.The medical device manufacturer and manufacturing location for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.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 and no images were provided for review.The user report contains information regarding helix break of the catheter.The user provided videos do not clearly show catheter break.Due to no physical sample or images provided the reported malfunction can not be confirmed as videos do not fully illustrate helix break.Therefore, the investigation is inconclusive for the reported flushing problem, break and material seperation.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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.Device not returned.
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Event Description
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It was reported that during a recanalization procedure, the tip end of the catheter was allegedly separated from the tube section.It was further reported that the device allegedly cannot be flushed upon removal.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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