Model Number BB524 |
Device Problems
Nonstandard Device (1420); Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with bb524 - carbon steel scalpel blades #24.According to the complaint description, the carbon steel scalpel blades are non sterile.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The malfunction is filed under (b)(4).
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Manufacturer Narrative
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Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Investigation results: visual investigation: the investigation was carried out visually and microscopically with the digital microscope and the digital-camera.We carried out a visual inspection of all the products.Every packaging was penetrated by the scalpel blades.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2 (5) probability of occurrence 1(5)) according to din en iso (b)(4) is still acceptable.Conclusion and measures / preventive measures: according to the quality standard and the dhr files, a material defect and a production defect can be excluded.Investigations lead to the assumption that the visible damages were caused by improper transport of the goods.Based upon the investigations results a capa is not necessary.
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Search Alerts/Recalls
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