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 Patient Involvement (2645)
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Event Date 10/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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As reported, the endo-flo irrigator device is being returned for evaluation.However, at this time has not been received.Based on the information provided to date, no conclusion can be made.Additional information has been requested.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 360 units released for distribution in march, 2018.If/when the sample is received and evaluated or additional information is provided, a supplemental mdr will be submitted.Sample not returned.
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Event Description
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As reported, on (b)(6) 2020, the endo-flo irrigator leaked saline from the device during priming.As reported, another device was used to complete the procedure.There were no pieces found detached from the device.There was no reported patient involvement.
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Event Description
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As reported, on (b)(6) 2020, the endo-flo irrigator leaked saline from the device during priming.As reported, another device was used to complete the procedure.There were no pieces found detached from the device.There was no reported patient involvement.
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Manufacturer Narrative
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As reported, the endo-flo irrigator device is being returned for evaluation.However, at this time has not been received.Based on the information provided to date, no conclusion can be made.Additional information has been requested.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march, 2018.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the device evaluation.The subject product was returned for evaluation.Functional evaluation of the sample found no fluid leak identified from the endo-flo tubing or pump housing or at the luer lock connection.The endo-flo was found to irrigate as intended with no fluid leaks identified.Evaluation of the sample could not reproduce the reported event.No manufacturing anomalies were found.Based on the sample evaluation and investigation performed, the reported event was unconfirmed.H3 other text : sample evaluated.
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Search Alerts/Recalls
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