Model Number 415068 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Type
malfunction
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Event Description
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As reported by the user facility: event 6: when the iv is started and the safsite is put on the blood rushes out.The hospital facility staff has to get the blue end cap and stick it back on, then hook up to contrast and pray that it works.Several times they have had to re-stick the patient.
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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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Event 6: this report has been identified as b.Braun medical internal report number (b)(4).Multiple unused samples in blister packages were returned for evaluation.A weapage test was performed checking the valve at 1 psi for 5 seconds and no leaking was observed.A pressure test was also performed checking for leakage at 45 psi and no leakage was observed.Based on the results of the sample evaluation, the product met internal specifications.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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