Model Number 405180 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/06/2023 |
Event Type
malfunction
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Event Description
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It was reported that 2 of the bd¿ spinal needle with quincke bevel tips were blocked and unable to inject.The following information was provided by the initial reporter: needles tips were blocked and was unable to inject.
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Manufacturer Narrative
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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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Manufacturer Narrative
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H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
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Event Description
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It was reported that 2 of the bd¿ spinal needle with quincke bevel tips were blocked and unable to inject.The following information was provided by the initial reporter: needles tips were blocked and was unable to inject.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 13-mar-2023.H6: investigation summary: eleven unopened samples received by our quality team for investigation.Upon visual evaluation, no defects or issues observed.Further testing was conducted, needles were not clogged.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.H3 other text : see h10.
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Event Description
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It was reported that 2 of the bd¿ spinal needle with quincke bevel tips were blocked and unable to inject.The following information was provided by the initial reporter: needles tips were blocked and was unable to inject.
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Search Alerts/Recalls
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