Catalog Number SL-2000M2095 |
Device Problems
Leak/Splash (1354); Detachment of Device or Device Component (2907)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 10/02/2023 |
Event Type
malfunction
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Event Description
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As reported by the user facility: brief inquiry description breaks at the connection and blood is leaking.Detailed inquiry description customer claim product is defective, breaks at the connection and blood is leaking.
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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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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number (b)(4).A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.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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