Catalog Number 367864 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Blood Loss (2597)
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Event Date 06/12/2020 |
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.(b)(4).
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Event Description
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It was reported that the bd intima-ii closed iv catheter system indwelling needle was found leaking during infusion.The following information was provided by the initial reporter, translated from (b)(6) to english: device was placed on the back of the left hand of patient.Normal infusion was conducted and routine catheter maintenance was conducted.On the next day, at around 8:30 am of the shift, blood was oozing from the puncture site.There was no high-pressure injection during the indwelling period, and the indwelling period was 2 days.
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Event Description
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It was reported that the bd intima-ii¿ closed iv catheter system indwelling needle was found leaking during infusion.The following information was provided by the initial reporter, translated from chinese to english: device was placed on the back of the left hand of patient.Normal infusion was conducted and routine catheter maintenance was conducted.On the next day, at around 8:30 am of the shift, blood was oozing from the puncture site.There was no high-pressure injection during the indwelling period, and the indwelling period was 2 days.
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Manufacturer Narrative
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Investigation: a device history review was conducted for lot number 9170850.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately a sample could not be obtained for our investigation preventing our engineers form determining a root cause; leakage at the inserter can be related to the angle of insertion or the application of medical dressing.The bd intima-ii should be inserted into the patient at an angle of approximately 15 - 30 degrees.
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Search Alerts/Recalls
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