Model Number 367283 |
Device Problems
Defective Component (2292); Physical Resistance/Sticking (4012)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 08/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).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® safety-lok¿ blood collection set there was poor sleeve function and needle stick - post use.The following information was provided by the initial reporter.The customer stated: "the safety shield doesn't cover the needle all the way, therefor resulting in a needle stick injury." customer states having a needle stick while attempting to close the butterfly safety closure.
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Event Description
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It was reported when using the bd vacutainer® safety-lok¿ blood collection set there was poor sleeve function and needle stick - post use.The following information was provided by the initial reporter.The customer stated: "the safety shield doesn't cover the needle all the way, therefor resulting in a needle stick injury." customer states having a needle stick while attempting to close the butterfly safety closure.
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for defective safety with the incident lot was not observed.Additionally, retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to defective safety 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 modes.Bd was not able to identify a root cause for the indicated failure modes.As stated in the ifu, please hold the end of safety shield and tubing, and slide the safety shield straight to cover the winged needle without holding wings.
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Search Alerts/Recalls
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