Catalog Number 383346 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the safety mechanism on the bd saf-t-intima¿ iv catheter safety system wouldn¿t activate during use.There was no report of exposure, injury, or medical intervention noted.
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Manufacturer Narrative
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Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: female.Event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.
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Event Description
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It was reported that the safety mechanism on the bd saf-t-intima¿ iv catheter safety system wouldn¿t activate during use.There was no report of exposure, injury, or medical intervention noted.
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Event Description
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It was reported that the safety mechanism on the bd saf-t-intima¿ iv catheter safety system wouldn¿t activate during use.There was no report of exposure, injury, or medical intervention noted.
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Manufacturer Narrative
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H.6.Investigation summary: the reported safety shield activation failure by customer was not confirmed after the sample was evaluated.Sample evaluation was performed; however, manufacturing process where the material is built was inspected and no equipment and instrument process that could cause this kind of damage were detected.Although the sample was received with the stylet bent, this sample could be activated without problems following the ifu d12556.Always refer to ifu for product usage recommendations.No corrective action required at the failure.Process fmea rm4797 was reviewed and there are proper controls in place to detect product malfunctions.Investigation conclusion: based on investigation results to date, the root cause is related with lack of training in the use of the product.
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Search Alerts/Recalls
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