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Catalog Number SL-2000M2095L |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 08/28/2023 |
Event Type
malfunction
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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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Event Description
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As reported by the user facility: event 16: detailed inquiry description: difficulty attaching the arterial lines to the saline port.It is hard to firmly attach, pulling in air and then the nurses are unable to return all the blood.It is also difficult to administer meds through this port, it seems they can't get past the seal on the needleless port.
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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number (b)(4).Event 16: one (1) video was submitted to the manufacturer for evaluation.Through visual examination of the video, it noted that the video depicted a customer applying a syringe on the locksite of the iv line of the artist set and applying force on the plunger with no movement occurring.Verifying all clamps and caps were remove, no fluid was able to pass through the locksite connection.The sample within the video is not within specification; the reported defect is confirmed.While a defect was confirmed, a root cause could not be determined.An approved project is in place to further address issues with lockstie occlusion.A review of manufacturing records was performed and indicated that there were no quality issues during the manufacturing of this lot related to the reported issue.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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