Model Number 367957 |
Device Problem
Fungus in Device Environment (2316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 a presence of mold.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: there was a "sterility failure during the manufacturing of dry tubes of lot 1253915.Six tubes showing the phenomenon have been sent from the emergency department to the laboratory.These photos of 4 tubes show elements resembling molds.".
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 a presence of mold.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: there was a "sterility failure during the manufacturing of dry tubes of lot 1253915.Six tubes showing the phenomenon have been sent from the emergency department to the laboratory.These photos of 4 tubes show elements resembling molds.".
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Manufacturer Narrative
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H6: 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 foreign matter (fm) was observed.The photos showed black and red dot-like fm inside the tube.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and the issue of fm 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 of fm.Bd was not able to identify a root cause for the indicated failure mode.
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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 a presence of mold.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: there was a "sterility failure during the manufacturing of dry tubes of lot 1253915.Six tubes showing the phenomenon have been sent from the emergency department to the laboratory.These photos of 4 tubes show elements resembling molds.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 09-mar-2022.H.6.Investigation: bd received thirty-four (34) samples and four (4) photos for investigation.The photos were reviewed and the indicated failure mode for foreign matter (fm) was observed.Black and red dot-like fm was observed inside the tube.The customer samples were visually examined and thirteen (13) of the samples were observed having the same fm on top of the gel.Additionally, one hundred (100) retention samples from bd inventory, were evaluated by visual examination and the issue of fm 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 of fm.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 there was a presence of mold.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: there was a "sterility failure during the manufacturing of dry tubes of lot 1253915.Six tubes showing the phenomenon have been sent from the emergency department to the laboratory.These photos of 4 tubes show elements resembling molds.".
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Search Alerts/Recalls
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