Catalog Number 388423 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/21/2020 |
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.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the bd insyte" iv catheter tip was found damaged before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the customer reported about catheter tip integrity.Before use in the operation room on october 15, a doctor found the damaged tip of the catheter.".
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Manufacturer Narrative
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Correction: the customer sent a photo showing the needle through the catheter prior to insertion within the unit packaging.This renders the device unusable and is not considered to be a reportable malfunction.
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Event Description
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It was reported that the bd insyte¿ iv catheter tip was found damaged before use.The following information was provided by the initial reporter, translated from japanese to english: "the customer reported about catheter tip integrity.Before use in the operation room on october 15, a doctor found the damaged tip of the catheter.".
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Search Alerts/Recalls
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