BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH 20GA X 1,16IN 1,1 X 30MM CATHETER; INTRAVASCULAR CATHETER
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Catalog Number 38833314 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
Extravasation (1842)
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Event Date 02/11/2022 |
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 1 bd angiocath 20ga x 1,16in 1,1 x 30mm catheter needle had ruptured the vein.The following information was provided by the initial reporter, translated from portuguese to english : when puncturing the vein at the time of introducing the catheter, the needle tears the catheter penetrating the vein causing it to rupture.
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Manufacturer Narrative
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H6: 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 1 bd angiocath 20ga x 1,16in 1,1 x 30mm catheter needle had ruptured the vein.The following information was provided by the initial reporter, translated from portuguese to english : when puncturing the vein at the time of introducing the catheter, the needle tears the catheter penetrating the vein causing it to rupture.
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Search Alerts/Recalls
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