Model Number 381411 |
Device Problem
Product Quality Problem (1506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/08/2022 |
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 bd insyte autoguard-n straight, 24g x 0.56" experienced a damaged catheter tip.The following information was provided by the initial reporter: when attempting to start a piv on my patient.[the catheter] tip was perforated around.
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Event Description
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It was reported that the bd insyte autoguard-n straight, 24g x 0.56" experienced a damaged catheter tip.The following information was provided by the initial reporter: when attempting to start a piv on my patient.[the catheter] tip was perforated around.
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Manufacturer Narrative
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H.6.Investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received four photographs which displayed 24gx0.56 insyte autoguard devices from lot number 2018214.This investigation addresses the first catheter seen in the photographs.The photograph shows a needle protruding through the catheter wall indicating a spear though.The reported issue was confirmed.During manufacturing, this may occur due to alignment of the set together station, bent tubing, or air blow inconsistency.There is a 100 percent automated vision system inspection and a sampling plan implemented for tip spear and lie distance, which mitigates the occurrence of this defect.It is also possible that this occurred in the user environment during tip adhesion break.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.The photos provided for this incident did not present sufficient evidence to to establish a definite root cause.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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