COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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Model Number 8813793009 |
Device Problems
Defective Component (2292); Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there was an issue with the catheter dimension.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during visual inspection and test, the catheter's middle part blocked and could not be inserted.It was stated that flushing was done but it was failed.The device was exchanged with a new one and the treatment was done to resolve the issue.There were no other products being utilized with the device.There were no other defects/damages found on the product observed.It was stated that the catheter match what is indicated on the label.There was no packaging damaged.There was no reported patient injury.
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Search Alerts/Recalls
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