DAVOL INC., SUB. C.R. BARD, INC. -1213643 ENDO-FLO IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Catalog Number 0037970 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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As reported, the bard/davol endo-flo irrigator leaks fluid when used with a reusable metal non-bard/davol trumpet valve instrument, and there is no leaking when the endo-flo irrigator is being used with disposable plastic instruments.A photo was provided that confirms a fluid leak at the luer lock location where the reusable metal non-bard/davol trumpet valve instrument connects to the irrigation tubing of the bard/davol endo-flo.Neither the bard/davol endo-flo, or the reusable metal non-bard/davol trumpet valve instrument has been provided for evaluation; therefore the potential cause of the incompatibility/leaking between the two devices could not be determined.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Not returned.
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Event Description
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As reported, during a gallbladder repair procedure on (b)(6) 2022, the bard/davol endo-flo irrigator leaked irrigation fluid when used with a reusable non-bard/davol trumpet valve.There was no reported patient injury.Reporter stated "the tubing does not leak with disposable instruments.It only leaks with the metal instrument.It does not leak when connecting to a plastic connector.When attaching the tubing to the metal irrigation instrument, there is significant leakage at the connector.".
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Search Alerts/Recalls
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