Catalog Number 38831114 |
Device Problem
Break (1069)
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Patient Problems
Hematoma (1884); Perforation of Vessels (2135)
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Event Date 02/21/2022 |
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 the bd insyte¿ autoguard¿ shielded iv catheter broke from the hub when introducing it into the patient's vein.The following information was provided by the initial reporter, translated from (b)(6): "when puncturing the child's vein twice, once with a 22 intravenous catheter and another with a 24 intravenous catheter, when introducing the catheter and pulling the mandrel, it tore the catheter".
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter broke from the hub when introducing it into the patient's vein.The following information was provided by the initial reporter, translated from portuguese: "when puncturing the child's vein twice, once with a 22 intravenous catheter and another with a 24 intravenous catheter, when introducing the catheter and pulling the mandrel, it tore the catheter".
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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.H3 other text : see h10.
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Search Alerts/Recalls
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