BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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Catalog Number 38833314 |
Device Problems
Break (1069); Material Separation (1562)
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Patient Problems
Bruise/Contusion (1754); Rupture (2208)
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Event Date 02/21/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter broke.The following information was provided by the initial reporter, translated from (b)(6) to english: when introducing the catheter and pulling the mandrel, it tore the catheter, breaking the veins, leaving catheter on one side and the mandrel on the other.When a catheter was taken out of the package and turned, the mandrel broke the catheter in my hand.
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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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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.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 the bd insyte¿ autoguard¿ shielded iv catheter broke.The following information was provided by the initial reporter, translated from portuguese to english: when introducing the catheter and pulling the mandrel, it tore the catheter, breaking the veins, leaving catheter on one side and the mandrel on the other.When a catheter was taken out of the package and turned, the mandrel broke the catheter in my hand.
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Search Alerts/Recalls
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