Catalog Number VS015010460 |
Device Problem
Device Disinfection Or Sterilization Issue (2909)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There was no similar additional nonconformance which could be considered related to the reported event recorded in the lot history.Upon testing six samples from batch #25114649 of fusion bioline, nodcar has reported a non-conformance with sterilization and deemed the entire batch to be non-sterile.A review of the production batch records demonstrates that this batch of fusion product had been manufactured, packaged and shipped fully compliant with our quality assurance processes and in conformance with our sterilization specification.We are awaiting return of the shipment to the manufacturing facility in order to complete our investigation.A supplemental report will be filed upon completion of our investigation.
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Event Description
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Maquet getinge group (b)(6) received a report from the (b)(4) alleging upon routine random testing the device was deemed to be non-sterile.
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Manufacturer Narrative
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(b)(4).The sample devices from the same lot were returned and processed through the nonconformance system (ncmr).The inspection of the returned products from egypt did not display any non-conformances, the third party laboratory results evidenced sterility, no further information was able to be obtained from the egyptian authority.Therefore, the reported complaint for "disinfection or sterilization issue" was not confirmed.
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Event Description
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Maquet (b)(4) received a report from (b)(6) alleging upon routine random testing the device was deemed to be non-sterile.
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Manufacturer Narrative
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(b)(4).The inspection of the returned products from egypt did not display any non-conformances, the third party laboratory results evidenced sterility, no further information was able to be obtained from the egyptian authority.Therefore, the reported complaint for "disinfection or sterilization issue" was not confirmed.
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Event Description
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Maquet (b)(4) received a report from the (b)(6) alleging upon routine random testing, the device was deemed to be non-sterile.
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Search Alerts/Recalls
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