Catalog Number 401622 |
Device Problem
Failure to Deliver (2338)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/14/2020 |
Event Type
malfunction
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Event Description
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It was reported that the plunger in the bd durasafe¿ tray syringe was difficult to push during use.The following information was provided by the initial reporter, translated from chinese: "in the department of anesthesiology, the syringe was stuck during use and could not push.".
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Manufacturer Narrative
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Initial reporter phone#: unknown.Initial reporter e-mail: unknown.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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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 03-nov-2022.A device history review was conducted for lot number 9077577.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, three syringes were returned to aid in our investigation.Each syringe represented on of the three volumes included in the anesthesia kit, one 2 milliliter(ml) syringe, one 7 ml syringe, and one 20ml syringe.All three samples were subjected to functional testing and found to be successfully depressed without the application of excessive force.The issue could not be confirmed.Unfortunately, without the ability to replicate the reported non-conformance our engineers could not determine a root cause for this event.H3 other text : see h10.
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Event Description
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It was reported that the plunger in the bd durasafe¿ tray syringe was difficult to push during use.The following information was provided by the initial reporter, translated from chinese: "in the department of anesthesiology, the syringe was stuck during use and could not push".
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Search Alerts/Recalls
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