Model Number 381444 |
Device Problems
Leak/Splash (1354); Improper Flow or Infusion (2954)
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Patient Problem
Exposure to Body Fluids (1745)
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Event Date 06/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported when using the bd insyte autoguard shielded iv catheter the blood control feature does not work.The following information was provided by the initial reporter.The customer stated: "the iv insertion does not have blood control features therefore blood pours out of the catheter tip after insertion and before the j-loop is hooked up.".
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Manufacturer Narrative
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H6: investigation summary bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.It should be noted that the reported material number is a device that does not contain the blood control feature.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly. our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported when using the bd insyte¿ autoguard¿ shielded iv catheter the blood control feature does not work.The following information was provided by the initial reporter.The customer stated: "the iv insertion does not have blood control features therefore blood pours out of the catheter tip after insertion and before the j-loop is hooked up.".
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Search Alerts/Recalls
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