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Model Number 8881560232 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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Event Description
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Customer reports: the syringe tips are breaking off.
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Manufacturer Narrative
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Please disregard this report number (1915484-2021-01241) as this report was inadvertently filed as a malfunction however based on clarification for this specific oem (outside equipment manufacturer) and product id, cardinal health is not considered to be the manufacturer subject to the reporting requirements of the mdr regulation as this oem repackages or otherwise changes the container, wrapper, or labeling of this device in furtherance of the distribution of the device from the original place of manufacture.
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Search Alerts/Recalls
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