Catalog Number 367958 |
Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/06/2022 |
Event Type
malfunction
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Manufacturer Narrative
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There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2116003, medical device expiration date: 2023-10-31, device manufacture date: 2022-04-26.Medical device lot #: 2067694, medical device expiration date: 2023-09-30, device manufacture date: 2022-03-08.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 the rubber stopper remained in tube (stopper/shield separation).This event occurred 4 times.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).This event occurred 4 times.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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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.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
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Search Alerts/Recalls
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