Model Number 8888566067 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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The customer reported the tap broke when turning it after removing the needle.It seemed to have resistance, this resulted in changing the drain and therefore repeating the procedure.Deterioration of the patient's health.Additional information received stated there was no injury to the patient, no medical intervention required, and no deterioration to the patient's health.
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Manufacturer Narrative
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The device history record (dhr) was reviewed showing all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.No sample has been received for evaluation.Without a sample we are unable to perform a thorough follow up investigation to determine the root cause of the reported condition or implement any corrective action.If a sample is returned later, this complaint will be reopened, and the investigation will be updated.This unit is supplied by a vendor and only packed at this manufacturing site.A supplier notification has been sent to the vendor.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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