Catalog Number 401622 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2021 |
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.
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Event Description
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It was reported that the needle in the bd durasafe¿ tray was damaged.The following information was provided by the initial reporter, translated from (b)(6) to english: "the medical staff opened the disposable anesthesia puncture package and found that the needle was damaged.They suspected the quality of the product, so they stopped using it".
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Event Description
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It was reported that the needle in the bd durasafe¿ tray was damaged.The following information was provided by the initial reporter, translated from chinese to english: "the medical staff opened the disposable anesthesia puncture package and found that the needle was damaged.They suspected the quality of the product, so they stopped using it".
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Manufacturer Narrative
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H6: investigation summary: a device history review was conducted for lot number 0220527.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue and encourages you to submit your sample for review.
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Search Alerts/Recalls
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