Model Number SL-2010M2096 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This report has been identified as b.Braun medical inc.Internal report number (b)(4), event 3.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 user facility: event 3 leaking occurred from the connection point of where the heparin syringe attached to the bloodline tubing.No injuries were reported.
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Manufacturer Narrative
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This report has been identified as b.Braun medical inc.Internal report number (b)(4), event 3.All information associated with this event was submitted to the bloodline manufacturer.According to the manufacturer investigation, the blood tubing set was not returned for evaluation.A review of the device history records for sl-2010m2096 from lot 10454067 was performed and indicated that there were no quality issues during the manufacturing process of this lot related to the reported issue.If additional pertinent information becomes available a follow-up report will be filed.
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Search Alerts/Recalls
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