Catalog Number 364957 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 11/16/2022 |
Event Type
Injury
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported when using the bd vacutainer® urine complete cup kit there was a needle stick injury - post use.The following information was provided by the initial reporter.The customer stated: "tech poke his finger with needle (transfer device).Tech decline any medical testing and/or intervention".
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Event Description
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It was reported when using the bd vacutainer® urine complete cup kit there was a needle stick injury - post use.The following information was provided by the initial reporter.The customer stated: "tech poke his finger with needle (transfer device).Tech decline any medical testing and/or intervention.".
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to needle exposure 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 needle exposure.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
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Search Alerts/Recalls
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