BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ IV CATHETER; INTRAVASCULAR CATHETER
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Catalog Number 38831114 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary - there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.
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Event Description
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It was reported that the tip of the bd insyte¿ iv catheter bent during the infusion.The following information was provided by the initial reporter, translated from portuguese: "peripheral access catheter showed resistance when removing from the patient and at the end of the procedure, it was observed that the tip had bent.".
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Search Alerts/Recalls
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