Catalog Number 393224 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Chemical Exposure (2570)
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Event Date 02/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone #: unknown.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 during use contrast leaked through top of port with a bd venflon¿ pro safety shielded iv catheter.The following information was provided by the initial reporter: iv contrast injected @ 3mls/sec through a 20g cannula.Due to faulty nature of the cannula the contrast leaked through the top port of the cannula.About 70mls of contrast came out of the top and leaked all over the patient's head, neck and chest, no contrast seen in the chest, therefore abandoned the scan.Had to re-cannulate and tap scan successful.
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Manufacturer Narrative
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H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
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Event Description
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It was reported that during use contrast leaked through top of port with a bd venflon¿ pro safety shielded iv catheter.The following information was provided by the initial reporter: iv contrast injected @ 3mls/sec through a 20g cannula.Due to faulty nature of the cannula the contrast leaked through the top port of the cannula.About 70mls of contrast came out of the top and leaked all over the patient's head, neck and chest, no contrast seen in the chest, therefore abandoned the scan.Had to re-cannulate and tap scan successful.
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Search Alerts/Recalls
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