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
malfunction
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Event Description
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As reported by the user facility: event 2: details of complaint (reported issue): stopcock on a few occasions has been cracked and leaking.Stopcock started leaking, propofol was leaking and infection control risk.Noticed stopcock cracked and changed out.
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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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Manufacturer Narrative
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Event 2: 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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