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Model Number 21-3256-24 |
Device Problems
Dull, Blunt (2407); Difficult or Delayed Separation (4044)
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Patient Problems
Pain (1994); Anxiety (2328)
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Event Date 01/04/2022 |
Event Type
malfunction
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Event Description
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It was reported that the cannulas are partly blunt, so repeated puncturing was necessary and the safety closure, which must be removed after puncture, was so tightly attached that a strong pull was necessary.There was no permanent damage and no extravasation, but the repeated puncturing of the cannula caused pain for the patients and fear of further puncturing due to the tight pulling of the closure.No invasive injuries occurred in relation with patients.
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Manufacturer Narrative
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Other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found the safety mechanism inactivated; no damage it can be observed on the base and needle.Functional testing found the sample returned was broken when trying to activate the arm due the needle base was too tight, complaint is confirmed.The root cause of the reported issue was found to be lack of adherence in procedure that indicate to lift the arm just enough to free the site to be turned to the final position, this step is a control process to assure the safety mechanism since this is a purchased component.An awareness notification was made to production personnel to explain the importance to adherence or following the procedure ? completed 17/november/2022.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.
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Search Alerts/Recalls
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