Model Number 405828 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Pma/510(k)#: enforcement discretion.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that tray cse whit27g4.7 we17g3.5 swc x3795 catheter broke.The following information was provided by the initial reporter: it was reported by the user facility that there are reports of the catheter breaking.
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Manufacturer Narrative
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H.6.Investigation: three photos were provided to our quality team for investigation.Upon visual inspection of the photo sample, was able to confirm the reported failure mode (broken catheter).A review of the internal manufacturing device record and raw material history files for the lot 0001393406 was performed and no recorded quality problems or rejections related to this incident were found, all procedural and functional requirements for product release have been met.Upon reviewing the production process of the trays 405828, it was identified that the catheters are visually inspected 100% in different parts of the process and in the last 12 months this situation has not been reported in the production line.Complaint investigation has determined the failure to be use related.H3 other text : see h.10.
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Event Description
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It was reported that tray cse whit27g4.7 we17g3.5 swc x3795 catheter broke.The following information was provided by the initial reporter: it was reported by the user facility that there are reports of the catheter breaking.
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Search Alerts/Recalls
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