Model Number 405671 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2021 |
Event Type
malfunction
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Event Description
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It was reported that the bd tray spn whit25g3.5 experienced missing depth markings.The following information was provided by the initial reporter: health professional called in to report that when they do spinals the marking isn't working.
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Manufacturer Narrative
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Initial reporter email: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the bd tray spn whit25g3.5 experienced missing depth markings.The following information was provided by the initial reporter: health professional called in to report that when they do spinals the marking isn't working.
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Manufacturer Narrative
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H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001424055 was performed and no recorded quality problems or rejections related to this incident were found.The sterilization records indicated no issues.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h10.
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Search Alerts/Recalls
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