Model Number 364880 |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2021 |
Event Type
malfunction
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Event Description
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It was reported when using the bd vacutainer® blood transfer device holder with female luer adapter the tube was unable to be filled completely.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: "during the transfer of blood into the tube by using btd, air bubbles got mixed into the tube and the tube was underfilled.".
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd received 1 used and 2 unused samples and 1 photo for investigation.The photo was reviewed and the indicated failure mode for air bubbles with the incident lot was not observed as the photo only shows a used blood transfer device (btd) back in its packaging.No defects could be observed from the photo.Additionally, the customer samples were evaluated by functional testing, each used to transfer colored water into tubes, and no issues were observed relating to air bubbles as all samples met specifications.An additional 48 retention samples from bd inventory were evaluated by visual examination, 12 of which were also evaluated by functional leakage and torque testing and no issues were observed relating to air bubbles as all samples met specifications.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 is unable to be confirmed for the indicated failure mode air bubbles.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® blood transfer device holder with female luer adapter the tube was unable to be filled completely.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: "during the transfer of blood into the tube by using btd, air bubbles got mixed into the tube and the tube was underfilled.".
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd received 1 used and 2 unused samples and 1 photo for investigation.The photo was reviewed and the indicated failure mode for air bubbles with the incident lot was not observed as the photo only shows a used blood transfer device (btd) back in its packaging.No defects could be observed from the photo.Additionally, the customer samples were evaluated by functional testing, each used to transfer colored water into tubes, and no issues were observed relating to air bubbles as all samples met specifications.An additional 48 retention samples from bd inventory were evaluated by visual examination, 12 of which were also evaluated by functional leakage and torque testing and no issues were observed relating to air bubbles as all samples met specifications.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 is unable to be confirmed for the indicated failure mode air bubbles.Bd was not able to identify a root cause for the indicated failure mode.
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Search Alerts/Recalls
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