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Model Number F0024274 |
Device Problems
Break (1069); Material Split, Cut or Torn (4008)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K031216.If additional information becomes available a follow-up report will be submitted.
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Event Description
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It was reported that there was an issue with monoplus suture.The client reported that in use during animal surgery, the suture had no strength capacity and broke straight away.
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Manufacturer Narrative
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Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market 26 units.There are no units in stock in b.Braun surgical's warehouse.We have received one open cassette.(cassette presentation only for veterinary use) the thread in the cassette received breaks easily and knot pull tensile strength test cannot be conducted.The thread is degraded by hydrolysis because of air humidity.The cassette must be used within 4 months once opened.The date of cassette's opening should be written in the cassette as indicated.Opening date is not written in the cassette received.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion: in spite of receiving a defective sample, without date of cassette's opening a suitable analysis cannot be performed.Nevertheless, we take note of this incidence and if any closed sample is received in the future, we will re-open the case and analyse it.The case is considered not confirmed.We regret any inconvenience this issue may have caused and thank you for your collaboration.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
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Search Alerts/Recalls
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