Model Number C2095442 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/17/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Manufacturing site evaluation: samples received: there are no samples available.Analysis and results: there are two previous complaints of the same reference-batch regarding other issue.(b)(4) units were manufactured and distributed of this code batch, there are no units in stock.Without any closed samples a study cannot be performed to determine if the product fulfills the oem requirements.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfills the oem requirements.Final conclusion: complaint is not justified.Without samples a study can not be performed to see if the affected product does not fulfill the oem requirements.Note is taken of this incidence and if any samples are received in the future, the case will be re-opened and analyzed.Please note that when no samples are received analyzing is very limited.Actions on product: based on the conclusion derived from investigation, it is not required to take an action on distributed product.Corrective/preventive actions: according to the internal procedures, there is no need to establish corrective or preventive actions.This complaint is recorded for trending analysis to assess if actions are needed in the future.
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Event Description
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Country of complaints: (b)(6).According to the costumer complaint:"the wire is loose at the needle, not allowing the suture performance.".
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Manufacturer Narrative
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Samples received: there are no samples available.Analysis and results: there are two previous complaints of the same reference-batch regarding other issue.Manufactured and distributed 1,620 units of this code batch.There are no units in our stock.Without any closed samples a study cannot be performed to determine if the product fulfills the oem requirements.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Final conclusion: complaint is not justified.Without samples a study can not be performed to see if the affected product does not fulfill the oem requirements.Note is taken of this incidence and if any samples are received in the future, the case will be re-opened and analyzed.Please note that when no samples are received analyzing is very limited.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.Device not returned.
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Search Alerts/Recalls
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