Catalog Number 367958 |
Device Problems
Separation Failure (2547); Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2022 |
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 when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was stopper pull out of the tube within a holder.The following information was provided by the initial reporter.The customer stated: there have been "an increasing number of tubes failing to decap correctly on the decapping instrument.The outer shield is removed while the rubber stopper remains in the tube.The have been several occurrences of such failures resulting in instrument errors and sampling probe crashes." (b)(6) 2022 - received additional information from the complainant.Nisaabd can you please provide name of the track and decapper so we can advise manufacturing? it¿s the glp (good lab practice) track system that is now owned by abbott under aas (abbott automation solutions).Website if you want to do some research: https://www.Corelaboratory.Abbott/int/en/offerings/brands/glp-systems the module is just called a decapper module (dm) ¿ i may be able to get some dm technical specifications from the abbott engineers but am unsure of ip restrictions and they may say no.
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Manufacturer Narrative
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The following fields were updated due to corrected information: annex a code: a150301.B.5 describe event or problem: it was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube the rubber stopper remained in tube (stopper/shield separation).The following information was provided by the initial reporter.The customer stated: there have been "an increasing number of tubes failing to decap correctly on the decapping instrument.The outer shield is removed while the rubber stopper remains in the tube.The have been several occurrences of such failures resulting in instrument errors and sampling probe crashes.".
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Event Description
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It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube the rubber stopper remained in tube (stopper/shield separation).The following information was provided by the initial reporter.The customer stated: there have been "an increasing number of tubes failing to decap correctly on the decapping instrument.The outer shield is removed while the rubber stopper remains in the tube.The have been several occurrences of such failures resulting in instrument errors and sampling probe crashes.".
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples, but four (4) photos were provided for investigation.The photos were reviewed and the indicated failure mode for closure separation was observed.Additionally, twenty four (24) bd inventory retention samples from each lot number provided were evaluated by functional testing and the issue of closure separation was not observed.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.This complaint has been confirmed for the indicated failure mode closure separation.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
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Event Description
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It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube the rubber stopper remained in tube (stopper/shield separation).The following information was provided by the initial reporter.The customer stated: there have been "an increasing number of tubes failing to decap correctly on the decapping instrument.The outer shield is removed while the rubber stopper remains in the tube.The have been several occurrences of such failures resulting in instrument errors and sampling probe crashes.".
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Search Alerts/Recalls
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