Catalog Number 383012 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2021 |
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 intima ii¿ iv catheter prn adapter there was leakage.The following information was provided by the initial reporter.The customer stated: "contrast extravasation was found during the enhanced ct examination of the patient the examination of the patient was immediately stopped when contrast extravasation was found at the heparin cap.After replacing the indwelling needle, the examination of the patient was continued without contrast extravasation, and no other adverse effects were caused to the patient.".
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Manufacturer Narrative
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H6: investigation: a device history review was conducted for lot number 9050858.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Additionally communication with the facility allowed our engineers to determine that the adaptor was not adequately tightened prior to use.Based on this information our engineers have determined that he root cause for this event was likely a combination of the use of high pressure injection through an infusion-only device and a loose adaptor.
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Event Description
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It was reported when using the bd intima ii¿ iv catheter prn adapter there was leakage.The following information was provided by the initial reporter.The customer stated: "contrast extravasation was found during the enhanced ct examination of the patient the examination of the patient was immediately stopped when contrast extravasation was found at the heparin cap.After replacing the indwelling needle, the examination of the patient was continued without contrast extravasation, and no other adverse effects were caused to the patient.".
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Search Alerts/Recalls
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