Catalog Number 8065752917 |
Device Problems
Material Integrity Problem (2978); Physical Property Issue (3008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported that the sleeves have been variable during procedures.It was reported that the sleeves are different colors, that they do not go through the incision very smoothly and that they rip easier.There was no report of patient harm.
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Manufacturer Narrative
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This is the fifth complaint reported for this finished goods lot; however the third for this issue.Review of the device history record indicates the order was built to specification.The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted.The root cause of the customer's complaint could not be established as a sample has not been received.Without a sample, it is not possible to isolate the root cause.After a thorough investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.(b)(4).
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Search Alerts/Recalls
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