Catalog Number 383691 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 safety mechanism failed and breaks during use with a bd nexiva¿ diffusics¿ 24g x 0.75 in global.The following information was provided by the initial reporter: successfully inserted the cannula into the patients vein.While activating the safety device and removing the needle the needle became detached from the safety gray colored casing, which remained attached to the back end of the cannula.Disposed the needle into the sharps bin.Detached the gray colored part of the device from the back end of the cannula and noticed that there was a small piece of metal lying on the patients skin.We kept the gray colored piece and the piece of metal for return.The cannula itself, in the patients vein was ok for use, however there was a failure with the safety mechanism in this incident.
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Manufacturer Narrative
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Investigation: a device history review was conducted for lot number 814838.Our records show that this is the only instance of this issue occurring in this production batch.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.Additionally the sample submitted by your facility was investigated by our quality engineers.During their evaluation they noted that the needle for this device was missing.Unfortunately without this component, the root cause for this complaint could not be determined at the conclusion of our review.
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Event Description
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It was reported that safety mechanism failed and breaks during use with a bd nexiva¿ diffusics¿ 24g x 0.75 in global.The following information was provided by the initial reporter: successfully inserted the cannula into the patients vein.While activating the safety device and removing the needle the needle became detached from the safety gray colored casing, which remained attached to the back end of the cannula.Disposed the needle into the sharps bin.Detached the gray colored part of the device from the back end of the cannula and noticed that there was a small piece of metal lying on the patients skin.We kept the gray colored piece and the piece of metal for return.The cannula itself, in the patients vein was ok for use, however there was a failure with the safety mechanism in this incident.
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Search Alerts/Recalls
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