Catalog Number 10013902 |
Device Problems
Leak/Splash (1354); Material Separation (1562)
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Patient Problem
Chemical Exposure (2570)
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Event Date 01/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd smartsite¿ extension set, low sorbing 1 smartsite¿ needle-free connector components separated and leakage.There was no report of patient impact.The following information was provided by the initial reporter: the tubing pulled away from the filter causing chemo to leak onto the floor, this is the third time this has happened (both subsequent times it was reported as well with no resolution).
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Manufacturer Narrative
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Investigation summary the customer reported tubing pulled away from filter and caused chemo leak, and returned one photo of the incident.The photo verifies the compliant of separation at filter.Without a physical sample investigation, the root cause cannot be determined.Device history record review for model 10013902 lot number 22069109 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
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Event Description
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It was reported while using bd smartsite¿ extension set, low sorbing 1 smartsite¿ needle-free connector components separated and leakage.There was no report of patient impact.The following information was provided by the initial reporter: the tubing pulled away from the filter causing chemo to leak onto the floor, this is the third time this has happened (both subsequent times it was reported as well with no resolution).
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Search Alerts/Recalls
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