Catalog Number 930815 |
Device Problems
Defective Component (2292); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.
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Event Description
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Material no.: 930815.Batch no.: unknown.It was reported by the sales representative that the back end fell off causing the glass to break into the surgical field and onto patient.If the problem is corrected.Was new product shipped out to replace the product that was recalled.No date of incident was given.She should have it in their system broken glass and solution went into the surgical field and on to the patient.
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Event Description
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It was reported by the sales representative that the back end fell off causing the glass to break into the surgical field and onto patient.
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Manufacturer Narrative
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Your facility did provide not photos/samples to aid in our quality engineer¿s investigation.With the lack of samples provided, bd was unable to confirm the failure mode as the end cap was detached from the applicator body.A device history record could not be evaluated as the lot number is unknown.Although the complaint could not be confirmed, the root cause is attributed to the equipment station for the end cap placement unto the applicator body.Corrective actions were initiated which led to bd conducting a voluntary recall on certain lots of the chloraprep hi- lite orange 26 ml applicator.Bd has confirmed that some of the product had an applicator end cap that was improperly secured during the manufacturing process which resulted in broken glass dropping out of the applicator.H3 other text : see narrative.
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Search Alerts/Recalls
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