CONMED UTICA FRAZIER INSTRUMENT 10 FRENCH 50/CASE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
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Model Number 0033100 |
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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Event Description
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During incoming inspection, the distributor rejected this device, 0033100, 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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Manufacturer Narrative
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Reported event ¿insufficient heatseal & (sterile) pouch or blister pack¿ was confirmed.Received five 0033100 in original packaging.Lot numbers were verified.Performed a visual inspection of the devices, one of the device was not sealed at one end while the other three devices had no obvious signs of a breach in the package.Performed a functional inspection, the devices were dye leak tested which indicated that the packaging did have 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.A two-year lot history review was conducted and found a total of 5 devices for this lot number.(b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.
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Search Alerts/Recalls
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