Model Number 381423 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 07/18/2022 |
Event Type
Injury
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Manufacturer Narrative
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H3.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 straight, 22g x 1.00" was involved with a patient going to the er.The following information was provided by the initial reporter: i recently had a bubble study done with a saline flush and iv.Both of them were from your company and i had an allergic reaction.I¿m not sure what i might have reacted to but i was covered in hives and had face swelling and had to go to the er.
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Manufacturer Narrative
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H.6.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.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
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Event Description
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It was reported that the bd insyte autoguard straight, 22g x 1.00" was involved with a patient going to the er.The following information was provided by the initial reporter: i recently had a bubble study done with a saline flush and iv.Both of them were from your company and i had an allergic reaction.I¿m not sure what i might have reacted to but i was covered in hives and had face swelling and had to go to the er.
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Search Alerts/Recalls
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