Model Number 456020 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/16/2022 |
Event Type
malfunction
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Event Description
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As reported by the user facility: description: stopcocks (blue) leaking despite tightening and securing all stopcocks.Leaking sedation medications, all stopcocks changed but still leaking.Old stopcocks (yellow) in stock on unit so blue stopcocks all thrown away from patient and changed to yellow stopcocks.No injury reported.
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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).One (1) used sample with packaging was returned for evaluation.The sample was visually and physically tested as per specification with passing results.No leakage was observed on the discofix.Based on the evaluation results, the reported defect was not confirmed.Retained units were evaluated and passed the internal testing.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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