Model Number 383322 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2021 |
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 when using the bd saf-t-intima¿ iv catheter safety system the catheter was defective/damaged/deformed.The following information was provided by the initial reporter.The customer stated: "when preparing for intravenous indwelling needle puncture for the patient, the nurse opened the outer package and found the needle bulging out.The needle could not be used.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-07-20.H6: investigation summary bd received a sample submitted for evaluation.The reported issue was not confirmed upon inspection of the sample.Since the reported failure was not confirmed a root cause cannot be established.A device history record review showed no non-conformances associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.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.H3 other text : see h10.
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Event Description
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It was reported when using the bd saf-t-intima¿ iv catheter safety system the catheter was defective/damaged/deformed.The following information was provided by the initial reporter.The customer stated: "when preparing for intravenous indwelling needle puncture for the patient, the nurse opened the outer package and found the needle bulging out.The needle could not be used.".
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Search Alerts/Recalls
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