Model Number 386880 |
Device Problems
Break (1069); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2022 |
Event Type
malfunction
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Event Description
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It was reported that while using bd cathena¿ safety iv catheter the catheters were bending and in cases breaking in half.The following information was provided by the initial reporter: "just an fyi; the cancer center rn¿s are not at all happy with the new iv catheters.Stated that they bend and is some cases break in half.They are all complaining about them.Complaining is not unusual but usually by now they have adjusted to the new product.
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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 while using bd cathena¿ safety iv catheter the catheters were bending and in cases breaking in half.The following information was provided by the initial reporter: "just an fyi; the cancer center rn¿s are not at all happy with the new iv catheters.Stated that they bend and is some cases break in half.They are all complaining about them.Complaining is not unusual but usually by now they have adjusted to the new product.
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Manufacturer Narrative
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H6: investigation summary: one photo was received by our quality team for evaluation.The photo was visually inspected for a bent needle and broken needle.From the photo, the catheter was observed to be bent together with the needle at the base of the catheter adapter.The needle did not appear to be broken.A device history record review found no non-conformances associated with this issue during production of this batch.A simulated sample was tested in the lie distance 100% vision inspection system.The vision inspection system was able to fail and reject this sample due to the sample being out of the camera scope if the needle was bent.As no sample was returned for evaluation, an actual root cause could not be established.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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