Model Number 303370 |
Device Problem
Device Contamination with Body Fluid (2317)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/06/2022 |
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 that "blood" was found on the bd¿ lever lock cannula lumen inside the unopened packaging.The following information was provided by the initial reporter: "i have a bd lever lock cannula (ref: (b)(4)) that came with blood inside of the package, on and inside the lumen of the cannula! so weird! the package is completely intact.".
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Manufacturer Narrative
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H6: investigation summary one sample and six photos of lever lock cannula (p/n 303370) batch 9268577 were received and evaluated.The sample was received in a sealed package and the body of the thread lock has multiple spots of dark embedded foreign matter.The condition observed is non-conforming per product specification.Potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded foreign matter is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.This type of defect is cosmetic and does not pose risk to the customer.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.
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Event Description
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It was reported that "blood" was found on the bd¿ lever lock cannula lumen inside the unopened packaging.The following information was provided by the initial reporter: "i have a bd lever lock cannula (ref: 303370) that came with blood inside of the package, on and inside the lumen of the cannula! soooo weird! the package is completely intact.".
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Search Alerts/Recalls
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