CONMED UTICA FRAZIER, WITH CNTL VENT + OBTR, 12 FR.; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
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Catalog Number 0033120 |
Device Problem
Delivered as Unsterile Product (1421)
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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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Received one 138114a in unopened original packaging.Lot number was verified.Performed a visual inspection of the device, there were no obvious signs of a breach.Performed a functional inspection, the devices were dye leak tested which indicated that the packaging had an insufficient heat seal.Root cause cannot be determined, however, based upon the evaluation of the device, a possible cause of this event is the device was encroaching into the seal.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 30 reports, regarding 68 devices, for this device family and failure mode.During this same time frame 4,143,590 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.00002.We will continue to monitor for trends through the complaint system to assure patient safety.
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Event Description
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During incoming inspection, the distributor rejected this device, 0033120, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.Performed a functional inspection, the devices were dye leak tested which indicated that the packaging had an insufficient heat seal.This will be reported as a malfunction with potential for injury upon reoccurrence.
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Search Alerts/Recalls
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