Catalog Number 366408 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/27/2020 |
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 the bd vacutainer® no additive (z) plus tubes had the stopper pop out of the tube.The following information was provided by the initial reporter: translated to english.The customer stated :caps are popping off during transport and spilling (tubes are half to 3/4 full).Sometimes the plastic part of the cap separates from the rubber stopper.Note: these tubes are used for aliquots so the caps are not staying on while reapplied.The non-additive tube cap goes back on but is super easy to pull off, with very little resistance.The original stoppers are popping off or coming apart (rubber stopper and clear cap separating).".
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Event Description
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It was reported the bd vacutainer® no additive (z) plus tubes had the stopper pop out of the tube.The following information was provided by the initial reporter: translated to english.The customer stated :caps are popping off during transport and spilling (tubes are half to 3/4 full).Sometimes the plastic part of the cap separates from the rubber stopper.Note: these tubes are used for aliquots so the caps are not staying on while reapplied.The non-additive tube cap goes back on but is super easy to pull off, with very little resistance.The original stoppers are popping off or coming apart (rubber stopper and clear cap separating).".
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Manufacturer Narrative
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H6: investigation summary bd received ten (10) samples from the customer for investigation.All samples were evaluated by functional testing and the indicated failure mode for stopper pop-off with the incident lot was observed.Bd was unable to determine the root cause of the customer's issue.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.
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Search Alerts/Recalls
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