BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC
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Catalog Number 381212 |
Device Problem
Material Perforation (2205)
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Patient Problems
Pain (1994); Perforation of Vessels (2135)
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Event Date 05/10/2022 |
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 needle speared through catheter while introducing bd insyte¿ iv catheter.This incident occurred several times, however, no serious injury reported.The following information was provided by the initial reporter, translated from french to english: when trying to reintroduce it into the catheter, the catheter is pierced.These incidents have been occurring daily since the delivery of this medical device.
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Manufacturer Narrative
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H.6 investigation summary: 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 needle speared through catheter while introducing bd insyte¿ iv catheter.This incident occurred several times, however, no serious injury reported.The following information was provided by the initial reporter, translated from french to english: when trying to reintroduce it into the catheter, the catheter is pierced.These incidents have been occurring daily since the delivery of this medical device.
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Search Alerts/Recalls
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