CONSOLIDATED MEDICAL EQUIPMENT COMPANY GOLDLINE,BTN,HOLS,EXT.BLADE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number 138114A |
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, 138114a, 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 four 138114a in original packaging.Lot number was verified.Performed a visual inspection of the device, there were no obvious signs of a breach.Evaluations were performed on two samples.Performed a functional inspection, the devices were dye leak tested per which indicated that the packaging had an insufficient heat seal on both packages.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 4 devices for this lot number.(b)(4).Per the instructions for use, the user is advised to inspect and test each device before use.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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