CONMED UTICA SOFT TIP FRAZIER INSTRM 10 FRENCH 20/CSE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
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Model Number 0031100 |
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 (b)(4) in original packaging.Lot number was verified.Performed a visual inspection, there is a hole in the seal where the device protruded through.Performed a functional inspection, the devices were dye leak tested which indicated that the packaging had an insufficient heat 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 28 complaints, regarding 55 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).This issue will continue to be monitored 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, 0031100, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This will be reported as a malfunction with potential for injury upon reoccurrence.
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Search Alerts/Recalls
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