COVIDIEN P400 PREM U/M 14FR TMP SNS CSD; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
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Model Number P4P14TSD |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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Event Description
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Customer reports: a 14 french foley catheter spontaneously became disconnected from the gravity drainage bag.The green plastic was still surrounding the end of the catheter.The foley catheter was replaced using a sterile technique.
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Manufacturer Narrative
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A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.Samples were not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported condition and determine the root cause.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.As part of continuous improvements, a corrective and preventative action plan has been opened to address the reported condition through a more robust investigation.The results of the investigation will be documented through the capa.This complaint will be used for tracking and trending purposes.
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