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Model Number 490105 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 06/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
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Event Description
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As reported by the user facility: event 2 : detailed inquiry description: leaking occurred at the same area.1st set, rn noticed blood leaking from lower y-site where the backcheck and caresite connects.Changed tubing, after priming with saline didn't notice leaking, but after 30 mins saw leaking blood at same area, lower y-site connection with tubing.No injury reported.
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Manufacturer Narrative
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Event 2: this report has been identified as b.Braun medical internal report number (b)(4).One unused sample in unopened packaging and two empty blisters were provided for evaluation.The sample was visually evaluated with no defects observed, in addition, the sample was leak tested per specification with passing results.Based on the evaluation results, the reported defect was not confirmed.The returned product was functionally tested per specification and the reported defect of leakage was not able to be replicated or confirmed.The exact root cause could be determined at this time.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
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Search Alerts/Recalls
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