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 01/24/2022 |
Event Type
Injury
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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) unused sample was provided for further evaluation.The sample was visually and physical evaluated as per specification with passing results, no leak/crack was detected on the discofix d500 4-way spin-lock.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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Event Description
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As reported by the user facility: event 3: details of complaint (reported issue): stopcock on a few occasions has been cracked and leaking."patient blood pressure dropped suddenly to critical level.Norepinephrine found to be leaking from connection between 2 stopcocks.Norepinephrine tubing moved to different part with dose increase.Once patient hemodynamics stabilized, all stopcocks replaced.".
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Manufacturer Narrative
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Event 3: this report has been identified as b.Braun medical internal report number (b)(4).One (1) unused sample with packaging was provided for evaluation.The sample was visually and physical evaluated as per specification with passing results, no leak/crack were detected.Based on the evaluation results, the reported defect was not confirmed.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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